Identity
- Trade Name
- Preston™ FDA UDI
- Generic Name
- Bone biopsy needle FDA UDI
- Model / Reference
- 00884450411803 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450411803 FDA UDI
- FDA Product Code
- DWO 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 Preston device is a high-quality, sterile needle designed for bone biopsy, allowing for accurate and precise access to samples. With its sharp bevel-edged, hollow tubular metal shaft, it provides a smooth and comfortable experience for patients.
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Also classified as Bone biopsy needle.
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- Pin Introducer, 11G x 5cm — Captiva Spine · Class I
- Bonopty Penetration Set — Apriomed AB · Class I
- Bonopty Penetration Set — Apriomed AB · Class I
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 b40bb558-7a37-4b99-8b29-d4d3795a522b 32 fields · synced Jul 18, 2026