Identity
- Trade Name
- Rotunda Katheter FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Rotunda Catheter S-shaped 8Fr. FDA UDI
- Model / Reference
- 320-723-080 FDA UDI
- Description
- Rotunda Catheter S-shaped 8Fr. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049197466080 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- Ureteral 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ureteral catheter
Rotunda Katheter by RZ-Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Bard® X-Force® Balloon Dilation Catheter — C. R. Bard, 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
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI 06607069-5bac-4049-9ebf-24e236a6fa35 33 fields · synced Jun 8, 2026