STERRAMED INC
Registration 3042248499FEI 3042248499Weehawken, NJ
Owner/operator: Sterramed Inc
- Develop Specifications But Do Not Manufacture At This Facility
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 35
- Added, last 12 months
- 35
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Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
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Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 35
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| HWJ | SterraMed Awl for HumerusAwlAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4540 | — |
| HXW | SterraMed Plaster BenderBenderAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4540 | — |
| HTW | SterraMed Drill Bit, 3.2 mm X 250 mmBit, DrillAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4540 | — |
| FZO | SterraMed Chisel Fiber Handle, 10 mmChisel, Surgical, ManualAdded Dec 17, 2025 | Class 1 | 21 CFR 878.4800 | — |
| HXD | SterraMed Staude Moore Sweetheart Clamp, 6 1/2"ClampAdded Nov 25, 2025 | Class 1 | 21 CFR 878.4800 | — |
| GDJ | SterraMed Clamp, Allis, Tissue, 6", 4x5 TeethClamp, Surgical, General & Plastic SurgeryAdded Nov 24, 2025 | Class 1 | 21 CFR 878.4800 | — |
| HTF | SterraMed Bruns Oval Curette, Straight, Size 0, 8"CuretteAdded Nov 25, 2025 | Class 1 | 21 CFR 878.4800 | — |
| HXZ | SterraMed Hit Wire Cutter, 12 inch LongCutter, WireAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4540 | — |
| HTE | SterraMed A O Type Periosteal Elevator with Fiber HandleElevatorAdded Nov 25, 2025 | Class 1 | 21 CFR 878.4800 | — |
| HWB | SterraMed Extractor BarExtractorAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4540 | — |
| HTD | SterraMed Adson Forceps, 1x2 Teeth, 4 3/4"ForcepsAdded Nov 25, 2025 | Class 1 | 21 CFR 878.4800 | — |
| HTJ | SterraMed Depth GaugeGauge, DepthAdded Dec 17, 2025 | Class 1 | 21 CFR 888.4300 | — |
and 23 more on your full dossier
What changed
- Dec 17, 2025Listing added: HWJ — SterraMed Awl for Humerus
- Dec 17, 2025Listing added: HXW — SterraMed Plaster Bender
- Dec 17, 2025Listing added: HTW — SterraMed Drill Bit, 3.2 mm X 250 mm
- Dec 17, 2025Listing added: FZO — SterraMed Chisel Fiber Handle, 10 mm
- Nov 25, 2025Listing added: HXD — SterraMed Staude Moore Sweetheart Clamp, 6 1/2"
- Nov 24, 2025Listing added: GDJ — SterraMed Clamp, Allis, Tissue, 6", 4x5 Teeth
- Nov 25, 2025Listing added: HTF — SterraMed Bruns Oval Curette, Straight, Size 0, 8"
- Dec 17, 2025Listing added: HXZ — SterraMed Hit Wire Cutter, 12 inch Long
- Nov 25, 2025Listing added: HTE — SterraMed A O Type Periosteal Elevator with Fiber Handle
- Dec 17, 2025Listing added: HWB — SterraMed Extractor Bar
- Nov 25, 2025Listing added: HTD — SterraMed Adson Forceps, 1x2 Teeth, 4 3/4"
- Dec 17, 2025Listing added: HTJ — SterraMed Depth Gauge
- Dec 17, 2025Listing added: GDH — SterraMed Capener Gouge, 10 mm
- Dec 17, 2025Listing added: FZY — Head Extractor Rod with Hammer and Hooks
- Nov 25, 2025Listing added: GDZ — SterraMed Knife Handle No. 3
- Nov 25, 2025Listing added: HRQ — SterraMed Crile Clamp, Curved, Satin, 5 1/2"
- Nov 24, 2025Listing added: HXK — SterraMed Mayo Hegar Needle Holder, TC, 6"
- Dec 17, 2025Listing added: GDG — SterraMed Skin Hook and Nerve Hook
- Dec 17, 2025Listing added: HWA — SterraMed DHS Screw Introducer and Impactor with Sleeve
- Dec 17, 2025Listing added: LGH — SterraMed Electric Plaster Cutting Saw with Box
- Dec 17, 2025Listing added: HWN — SterraMed Compression Device
- Nov 25, 2025Listing added: HXL — SterraMed Bergman Mallet, 1 lb, 9 1/2"
- Nov 25, 2025Listing added: LXH — SterraMed AMP Head Gauge, 37 to 53 mm
- Dec 17, 2025Listing added: HWM — SterraMed Osteotome Fiber Handle, 10 mm
- Dec 17, 2025Listing added: HTR — SterraMed AMP Rasp with Tomy Bar
- Dec 17, 2025Listing added: HTO — SterraMed DCS Triple Reamer
- Nov 25, 2025Listing added: GAD — SterraMed Bennett Retractor, Narrow Blade, 1 3/4" x 9 1/2"
- Dec 17, 2025Listing added: FFO — SterraMed Gelpi Retractor, 6 inch
- Nov 25, 2025Listing added: HTX — SterraMed Kerrison Rongeur
- Dec 17, 2025Listing added: GDR — SterraMed H D Plaster Cutting Saw
- Nov 21, 2025Listing added: LRW — SterraMed Bandage Scissor, Heavy, Black, Universal, 7.5"
- Dec 17, 2025Listing added: HXX — SterraMed Screwdriver for 3.4 mm and 2.9 mm Screws
- Dec 17, 2025Listing added: HWO — SterraMed Tibial Awl, Curved
- Dec 17, 2025Listing added: BSR — SterraMed Tube Introducer
- Nov 25, 2025Listing added: FTY — SterraMed Surgical Ruler, 6 1/2"