Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Abdominal paracentesis needle, single-use FDA UDI
- Device Name
- Percutaneous Entry Needle with Venous Bevel FDA UDI
- Model / Reference
- G02304 FDA UDI
- Description
- Percutaneous Entry Needle with Venous Bevel FDA UDI
Identifiers
- Catalog Number
- SDN-21-7.0-CSV FDA UDI
- Primary DI / UDI-DI
- 00827002023048 FDA UDI
- FDA Product Code
- DRC FDA UDI
- GMDN Term
- Abdominal paracentesis needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1390 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Abdominal paracentesis needle, single-use
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal paracentesis needle, single-use.
- BREEZE® APD — MEDICAL COMPONENTS INC · Class II
- BREEZE® XS APD — MEDICAL COMPONENTS INC · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- BREEZE® XS APD — MEDICAL COMPONENTS INC · Class II
- Skater™ Safety Centesis Catheter — Argon Medical Devices, Inc. · Class I
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC · Class II
- BREEZE® XS APD — MEDICAL COMPONENTS INC · Class II
- BREEZE® APD — MEDICAL COMPONENTS INC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 56f08d8c-909b-49c0-acab-7b4644c5078a 36 fields · synced Jun 8, 2026