Identity
- Trade Name
- TLAB Transjugular Liver Biopsy System FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- TLAB Transjugular Liver Biopsy System FDA UDI
- Model / Reference
- TL-18N FDA UDI
- Description
- TLAB Transjugular Liver Biopsy System FDA UDI
Identifiers
- Catalog Number
- TL-18N FDA UDI
- Primary DI / UDI-DI
- 00886333218530 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
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: Soft-tissue biopsy needle, single-use
TLAB Transjugular Liver Biopsy System by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy needle, single-use.
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Chiba needle — Möller Medical GmbH · Class II
- Inrad — Inrad · Class II
- CUSTOMED — Customed, Inc. · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Manual TruCut Biopsy Cannula — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI eada36d2-1dd1-483b-847d-b6ef502cd436 36 fields · synced Jun 9, 2026