Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Chiba Biopsy Needle EUDAMEDFDA UDI
- Model / Reference
- DCHN-18-20.0-U EUDAMEDG03020 FDA UDI
- Description
- Chiba Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- DCHN-18-20.0-U FDA UDI
- Primary DI / UDI-DI
- 00827002030206 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002030206 EUDAMED
- FDA Product Code
- MJG FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
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: Body aspiration needle, single-use
Cook by Cook Incorporated — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Body aspiration needle, single-use.
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- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- CHIBA SONO — Pajunk GmbH Medizintechnologie · Class II
- FNA WESTCOTT — Medax Unipersonale Srl · Class II
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI 93350a58-e0e6-47a2-8d46-24f0e20ba8f3 36 fields · synced Jun 18, 2026
- EUDAMED 6e16dd2a-5a20-42ec-a0c0-9dfaf457a294 61 fields · synced Jun 18, 2026