Identity
- Trade Name
- Key Surgical Needle Counters FDA UDI
- Generic Name
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
- Device Name
- Needle Counters, Sterile, 20 Count, Dual Magnetic, Solid Lid, 50 per box FDA UDI
- Model / Reference
- NC-20-121 FDA UDI
- Description
- Needle Counters, Sterile, 20 Count, Dual Magnetic, Solid Lid, 50 per box FDA UDI
Identifiers
- Catalog Number
- NC20121 FDA UDI
- Primary DI / UDI-DI
- 00849771030553 FDA UDI
- FDA Product Code
- GAB FDA UDI
- GMDN Term
- Sharp surgical instrument counting tray/pad, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Key Surgical Needle Counters by Key Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Key Surgical, LLC
Sources (1)
- FDA UDI 87b938d9-4f8d-4f11-9d43-2e6854b1ee30 36 fields · synced Jun 1, 2026