Identity
- Trade Name
- mahe medical GmbH FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- TI HBS self-drilling high compression _x000D_screw,cannulated,34mm _x000D_ FDA UDI
- Model / Reference
- HBS-1002-34S FDA UDI
- Description
- TI HBS self-drilling high compression _x000D_screw,cannulated,34mm _x000D_ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050659465459 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
mahe medical GmbH by mahe medical gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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- QWIX — Newdeal Sas · Class II
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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
- mahe medical gmbh
Sources (1)
- FDA UDI 638485f1-d204-46df-831d-ffce8acc2dc4 33 fields · synced Jun 8, 2026