Identity
- Trade Name
- Westbrook™ FDA UDI
- Generic Name
- Bone biopsy needle FDA UDI
- Model / Reference
- 00884450411858 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450411858 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
Category: Bone biopsy needle
The Westbrook device is a high-quality, sterile bone biopsy needle designed for obtaining samples from any bone in the body. This single-use instrument features a sharp bevel-edged, hollow tubular metal design and an ejector rod to facilitate easy removal of specimens.
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Also classified as Bone biopsy needle.
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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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 5ab4bf4e-356e-423e-ac47-7a4dcbb81fc2 32 fields · synced Jul 22, 2026