Identity
- Trade Name
- COMPLETE-CHIBA FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Chiba type needle with quincke point 23 G; 15 cm FDA UDI
- Model / Reference
- COMPLETE-CHIBA FDA UDI
- Description
- Chiba type needle with quincke point 23 G; 15 cm FDA UDI
Identifiers
- Catalog Number
- CCH2315 FDA UDI
- Primary DI / UDI-DI
- 08033959221679 FDA UDI
- 510(k) Number
- K051506 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG 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
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
No
FDA UDI
Category: Body aspiration needle, single-use
Complete-Chiba by Sterylab Srl — 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
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · Class II
- CHIBA SONO — Pajunk GmbH Medizintechnologie · Class II
Cleared under the same submission
K051506 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
- Sterylab Srl
Sources (1)
- FDA UDI 0125e130-a12c-4562-bd93-92da1ad4fc24 35 fields · synced May 30, 2026