Identity
- Trade Name
- DB Surgical FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Sterile Distraction Screw, 12mm, Blunt FDA UDI
- Model / Reference
- S-0088 FDA UDI
- Description
- Sterile Distraction Screw, 12mm, Blunt FDA UDI
Identifiers
- Catalog Number
- S-0088 FDA UDI
- Primary DI / UDI-DI
- 00888515323339 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical retractor/retraction system blade, reusable
DB Surgical by Boss Instruments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Boss Instruments, Ltd.
Sources (1)
- FDA UDI f57e71e7-63bc-495b-86c8-26a5762a3a2a 35 fields · synced Jun 9, 2026