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Nephro-Cath Nephrostomy Drainage Catheter
FDA UDIClass I (US FDA UDI)
by Uresil Corp.
Identity
- Trade Name
- Nephro-Cath Nephrostomy Drainage Catheter FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 10F FDA UDI
- Model / Reference
- NCL2-1035H FDA UDI
- Description
- HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 10F FDA UDI
Identifiers
- Catalog Number
- NCL2-1035H FDA UDI
- Primary DI / UDI-DI
- 00817640020356 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 10 French FDA UDILength — 28 Centimeter FDA UDI
Category: Nephrostomy catheter
Nephro-Cath Nephrostomy Drainage Catheter by Uresil Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrostomy catheter.
- Flexima™ — Boston Scientific · Class I
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- Cook — COOK INCORPORATED · Class II
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- Total Abscession — ANGIODYNAMICS, INC · Class I
- Percuflex™ — Boston Scientific · Class II
- Cobra — COOK INCORPORATED · Class II
- EZDilate — Gyrus Acmi, 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
- Uresil Corp.
Sources (1)
- FDA UDI 06fc05eb-8482-4e0b-8593-cac6838043eb 36 fields · synced May 30, 2026