Identity
- Trade Name
- Single Use Surgical Professional FDA UDI
- Generic Name
- Manual surgical saw, rigid FDA UDI
- Device Name
- Gigli Saw 300mm and Handles, Pair, 55mm FDA UDI
- Model / Reference
- S212 FDA UDI
- Description
- Gigli Saw 300mm and Handles, Pair, 55mm FDA UDI
Identifiers
- Catalog Number
- S212 FDA UDI
- Primary DI / UDI-DI
- 05055299103111 FDA UDI
- FDA Product Code
- GDR FDA UDI
- GMDN Term
- Manual surgical saw, rigid 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
Dimensions & Sizes
- Size
- Length — 300 Millimeter FDA UDI
Single Use Surgical Professional by Eakin Surgical Limited — 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
- Eakin Surgical Limited
Sources (1)
- FDA UDI 2fb2dc3a-08e2-4e82-a5dd-fbabb5b80951 37 fields · synced Jun 7, 2026