Identity
- Trade Name
- Lee Medical FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Adult Long LEE ® Bone Marrow Harvest Needle 11 Gauge – 5 1/2 inch (138mm) FDA UDI
- Model / Reference
- TP-115 FDA UDI
- Description
- Adult Long LEE ® Bone Marrow Harvest Needle 11 Gauge – 5 1/2 inch (138mm) FDA UDI
Identifiers
- Catalog Number
- TP-115 FDA UDI
- Primary DI / UDI-DI
- 00850048404069 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use 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 marrow biopsy needle, single-use
Lee Medical by Tarca LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Monoject — Cardinalhealth · Class II
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- Faset — Dio Medical Co., Ltd. · U
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 1d718101-f562-4f26-a46b-71d7b4819b0e 34 fields · synced May 30, 2026