Identity
- Trade Name
- Lee Medical FDA UDI
- Generic Name
- Bone biopsy needle FDA UDI
- Device Name
- Adult Long LEE ® Bone Marrow Biopsy Needle 11 Gauge – 5 1/2 inch (138mm) FDA UDI
- Model / Reference
- B-115 FDA UDI
- Description
- Adult Long LEE ® Bone Marrow Biopsy Needle 11 Gauge – 5 1/2 inch (138mm) FDA UDI
Identifiers
- Catalog Number
- B-115 FDA UDI
- Primary DI / UDI-DI
- 00850048404038 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone biopsy needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
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
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
Lee Medical by Tarca LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone biopsy needle.
- Bonopty Biopsy Set — Apriomed AB · Class I
- Madison™ — Merit Medical Systems, Inc. · Class I
- Westbrook™ — Merit Medical Systems, Inc. · Class I
- Madison™ — Merit Medical Systems, Inc. · Class I
- Kensington™ — Merit Medical Systems, Inc. · Class I
- Madison™ — Merit Medical Systems, Inc. · Class I
- Bonopty Biopsy Set — Apriomed AB · Class I
- Madison™ — Merit Medical Systems, Inc. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Tarca LLC
Sources (1)
- FDA UDI eca1e4ce-771f-401e-94ea-cb2805a5770e 34 fields · synced Jun 8, 2026