GFA PRODUCTION INC
Registration 3045526618FEI 3045526618Clearwater, FL
Owner/operator: GFA Production 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.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 25
- Added, last 12 months
- 25
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
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.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
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 25
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KXF | Cotton Tipped ApplicatorsApplicator, Absorbent Tipped, Non-SterileAdded Jul 31, 2026 | Class 1 | 21 CFR 880.6025 | — |
| KXG | Sterile Cotton Tipped Applicator, Disposable Sampling SwabApplicator, Absorbent Tipped, SterileAdded Jul 31, 2026 | Class 1 | 21 CFR 880.6025 | — |
| ITG | Triangular BandageBandage, CastAdded Jul 31, 2026 | Class 1 | 21 CFR 890.3025 | — |
| FQM | Roller Gauze Bandage; Bandage, Elastic, Self Adhering; Pressure Bandages; Blood Stopper Dressing;Bandage, ElasticAdded Jul 31, 2026 | Class 1 | 21 CFR 880.5075 | — |
| KME | Emergency BlanketBedding, Disposable, MedicalAdded Jul 31, 2026 | Class 1 | 21 CFR 880.6060 | — |
| GEC | MoleskinBrush, Scrub, Operating-RoomAdded Jul 31, 2026 | Class 1 | 21 CFR 878.4800 | — |
| FMA | Wooden Tongue Depressor, Tongue DepressorDepressor, Tongue, Non-SurgicalAdded Jul 31, 2026 | Class 1 | 21 CFR 880.6230 | — |
| NAE | Burn dressing, Burn gel dressingDressing, Wound, Hydrogel Without Drug And/Or BiologicAdded Jul 31, 2026 | Class 1 | 21 CFR 878.4022 | — |
| NAC | Hydrocolloid Dressing, Hydrophilic wound dressingDressing, Wound, HydrophilicAdded Jul 31, 2026 | Class 1 | 21 CFR 878.4018 | — |
| LZB | Finger CotFinger CotAdded Jul 31, 2026 | Class 1 | 21 CFR 880.6250 | — |
| OHO | First Aid Kit Without DrugGeneral, Plastic SurgeryAdded Jun 12, 2026 | Class 1 | 21 CFR 878.4014 | — |
| HTD | Tweezers/ForcepsForcepsAdded Jul 31, 2026 | Class 1 | 21 CFR 878.4800 | — |
and 13 more on your full dossier
What changed
- Jul 31, 2026Listing added: KXF — Cotton Tipped Applicators
- Jul 31, 2026Listing added: KXG — Sterile Cotton Tipped Applicator, Disposable Sampling Swab
- Jul 31, 2026Listing added: ITG — Triangular Bandage
- Jul 31, 2026Listing added: FQM — Roller Gauze Bandage; Bandage, Elastic, Self Adhering; Pressure Bandages; Blood Stopper Dressing;
- Jul 31, 2026Listing added: KME — Emergency Blanket
- Jul 31, 2026Listing added: GEC — Moleskin
- Jul 31, 2026Listing added: FMA — Wooden Tongue Depressor, Tongue Depressor
- Jul 31, 2026Listing added: NAE — Burn dressing, Burn gel dressing
- Jul 31, 2026Listing added: NAC — Hydrocolloid Dressing, Hydrophilic wound dressing
- Jul 31, 2026Listing added: LZB — Finger Cot
- Jun 12, 2026Listing added: OHO — First Aid Kit Without Drug
- Jul 31, 2026Listing added: HTD — Tweezers/Forceps
- Jul 31, 2026Listing added: NAB — Sterile Gauze Pad; Sterile Non-woven sponges ; Non-Adherent Pads; Combine Pad;
- Jul 31, 2026Listing added: KGB — CPR face shield
- Jul 31, 2026Listing added: IMD — Instant Cold Compress
- Jul 31, 2026Listing added: HMP — Sterile Eye Pad
- Jul 31, 2026Listing added: FMP — Face Shield
- Jul 31, 2026Listing added: JOK — Scissors
- Jul 31, 2026Listing added: HOY — Eye Shield, Eye Cover
- Jul 31, 2026Listing added: NOC — Splint
- Jul 31, 2026Listing added: QQS — Disposable Skin Stapler
- Jul 31, 2026Listing added: KYZ — Surgical Scrub Brush
- Jul 31, 2026Listing added: KGX — First Aid tape, Adhesive bandage; First Aid tape
- Jul 31, 2026Listing added: FQZ — Thermometer Strip
- Jun 12, 2026Listing added: LRR — First Aid Kit With Drug