Identity
- Trade Name
- Rutner FDA UDI
- Generic Name
- Suprapubic drainage catheter FDA UDI
- Device Name
- Rutner Suprapubic Balloon Catheter Set FDA UDI
- Model / Reference
- G16567 FDA UDI
- Description
- Rutner Suprapubic Balloon Catheter Set FDA UDI
Identifiers
- Catalog Number
- J-RSB-162200 FDA UDI
- Primary DI / UDI-DI
- 00827002165670 FDA UDI
- FDA Product Code
- KOB FDA UDI
- GMDN Term
- Suprapubic drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5090 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
Yes
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: Suprapubic drainage catheter
Rutner by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suprapubic drainage catheter.
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- Bardex® Pezzer Model Drain — C. R. Bard, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- Suprapubic Catheter Sets — Yushin Medical Co., Ltd. · Class IIb
- MiniSPC Button — Applied Medical Technology, Inc. · Class II
- MiniSPC Button — Applied Medical Technology, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 7e809bd5-650b-4562-b948-dd4e9628564c 36 fields · synced Jun 8, 2026