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T-Lok™ Bone Marrow Biopsy Needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref DBMNJ1104D
Identity
- Trade Name
- T-Lok Bone Marrow Biopsy EUDAMEDT-Lok™ Bone Marrow Biopsy Needle FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- T-Lok Bone Marrow Biopsy Needle EUDAMEDT-Lok™ Bone Marrow Biopsy Needle 11ga x 4in FDA UDI
- Model / Reference
- DBMNJ1104D EUDAMEDFDA UDI
- Description
- T-Lok™ Bone Marrow Biopsy Needle 11ga x 4in FDA UDI
Identifiers
- Catalog Number
- DBMNJ1104D FDA UDI
- Primary DI / UDI-DI
- 20886333007909 EUDAMED00886333007905 FDA UDI
- Basic UDI-DI
- B-20886333007909 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone marrow biopsy needle, single-use
T-Lok™ Bone Marrow Biopsy Needle by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy needle, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI 73aedeb6-b26e-4f82-8514-722b49923941 36 fields · synced Jul 12, 2026
- EUDAMED 82ec8b26-df84-4b31-8d07-96c293429d1a 61 fields · synced Jun 14, 2026