Identity
- Trade Name
- Percuflex Locking Loop FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- Nephrostomy Catheter FDA UDI
- Model / Reference
- M0064101120 FDA UDI
- Description
- Nephrostomy Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729005230 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
Yes
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
MR Safe FDA UDI
Category: Nephrostomy catheter
Percuflex Locking Loop by Boston Scientific — 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
- 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
- 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
- Boston Scientific
Sources (1)
- FDA UDI 85df02b1-ccc9-432b-8103-81198340e286 34 fields · synced May 30, 2026