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Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 FDA UDI
- Generic Name
- Sterilizer/disinfector rack instrument-holding insert, single-use FDA UDI
- Device Name
- Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All clips are made w/ Barium Sulfate. Refer to GIC190. FDA UDI
- Model / Reference
- GIC190R FDA UDI
- Description
- Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All clips are made w/ Barium Sulfate. Refer to GIC190. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356101812 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Sterilizer/disinfector rack instrument-holding insert, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilizer/disinfector rack instrument-holding insert, single-use
Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Sterilizer/disinfector rack instrument-holding insert, single-use.
- Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 1.900" — CYGNUS MEDICAL L.L.C. · Class I
- Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 — CYGNUS MEDICAL L.L.C. · Class I
- Gator Instrument Clip, 100% Nylon 6 with Barium Sulfate (Radio Opaque), 2.700" — CYGNUS MEDICAL L.L.C. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI a39d5941-4ad0-47f5-9ef0-bcd6f8acc47e 33 fields · synced May 30, 2026