Identity
- Trade Name
- Bonopty Extended Drill FDA UDI
- Generic Name
- Bone biopsy needle FDA UDI
- Device Name
- Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G. FDA UDI
- Model / Reference
- 10-1074 FDA UDI
- Description
- Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G. FDA UDI
Identifiers
- Catalog Number
- 10-1074 FDA UDI
- Primary DI / UDI-DI
- 07350031350746 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Bone biopsy needle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
- Needle Gauge — 15 Gauge FDA UDILength — 16 Centimeter FDA UDI
Category: Bone biopsy needle
Bonopty Extended Drill by Apriomed AB — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Apriomed AB
Sources (1)
- FDA UDI 621fcb15-74a5-443a-8ea8-1a0f56ca8f58 37 fields · synced May 31, 2026