Identity
- Trade Name
- Access Needle FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires. FDA UDI
- Model / Reference
- N10222250 FDA UDI
- Description
- Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires. FDA UDI
Identifiers
- Catalog Number
- N10222250 FDA UDI
- Primary DI / UDI-DI
- 15711055000274 FDA UDI
- FDA Product Code
- GCB FDA UDI
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDILength — 25 Centimeter FDA UDI
Category: Interventional radiology percutaneous-access kit, single-use
Access Needle by Mermaid Medical A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Interventional radiology percutaneous-access kit, single-use.
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- PMI — PROGRESSIVE MEDICAL, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mermaid Medical A/S
Sources (1)
- FDA UDI 970012a6-87af-46eb-a414-64f17e493d4c 37 fields · synced Jun 1, 2026