Identity
- Trade Name
- allDrain FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm FDA UDI
- Model / Reference
- allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm FDA UDI
- Description
- allDrain Percutaneous Nephrostomy Catheter Pigtail- 8F, 30cm FDA UDI
Identifiers
- Catalog Number
- PCN-P8 FDA UDI
- Primary DI / UDI-DI
- 00812261012292 FDA UDI
- FDA Product Code
- GBO FDA UDI
- GMDN Term
- Nephrostomy catheter 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
No
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: Nephrostomy catheter
allDrain by Allwin Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrostomy catheter.
- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
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- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
- Malecot — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Kolibri — Coloplast A/S · U
- Total Abscession — ANGIODYNAMICS, INC · Class I
- Percuflex™ — Boston Scientific · 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
- Allwin Medical Devices, Inc.
Sources (1)
- FDA UDI e71fde63-7bd2-457e-941e-112bd5fe5717 35 fields · synced Jun 1, 2026