Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Liver Biopsy Kit FDA UDI
- Model / Reference
- IPN036849 FDA UDI
- Description
- Liver Biopsy Kit FDA UDI
Identifiers
- Catalog Number
- AK-00370 FDA UDI
- Primary DI / UDI-DI
- 10801902120110 FDA UDI
- 510(k) Number
- K874062 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Body aspiration 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Category: Body aspiration needle, single-use
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
- Arthrex® — Arthrex, Inc. · Class I
- ECOJEKT — H.S. HOSPITAL SERVICE SPA · Class I
- Chiba Needle Marked — REMINGTON MEDICAL, INC. · Class I
- Echotip — COOK INCORPORATED · Class I
- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · Class II
Cleared under the same submission
K874062 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 17ef3381-2dfe-4b98-82fe-2f6599cceaf1 36 fields · synced May 30, 2026