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ACURA Stabilization System - Cap Driver, Non Threaded
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ACURA Stabilization System - Cap Driver, Non Threaded FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Cap Driver, Non Threaded FDA UDI
- Model / Reference
- F004.0320 FDA UDI
- Description
- Cap Driver, Non Threaded FDA UDI
Identifiers
- Catalog Number
- F004.0320 FDA UDI
- Primary DI / UDI-DI
- B922F00403200 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
ACURA Stabilization System - Cap Driver, Non Threaded by Indius Medical Technologies Private Limited — Class I — FDA UDI — listed in FDA GUDID
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Indius Medical Technologies Private Limited
Sources (1)
- FDA UDI 121e1d8b-8ad2-4bd2-89d6-c9802340760f 35 fields · synced May 31, 2026