Identity
- Trade Name
- Coaxial needle FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Model / Reference
- COX-1010-20-0109 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260277171322 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Needle guide, 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
Yes
FDA UDI
Category: Needle guide, single-use
Coaxial needle by Möller Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Verza Guidance System Master Carton — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Gangi-SoftGuard Coaxial Needle — Apriomed AB · 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
- Möller Medical GmbH
Sources (1)
- FDA UDI bfb9d26d-504a-43f6-b36f-c91a4b9aba84 32 fields · synced Jun 9, 2026