Identity
- Trade Name
- OlyCath Straight 2 Eye 5 French FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Ureteral catheter, L. 80cm straight open, 2 eyes, 05 CH/Fr FDA UDI
- Model / Reference
- ROTA5200ST245 FDA UDI
- Description
- Ureteral catheter, L. 80cm straight open, 2 eyes, 05 CH/Fr FDA UDI
Identifiers
- Catalog Number
- OLCAS25 FDA UDI
- Primary DI / UDI-DI
- 03700512967927 FDA UDI
- 510(k) Number
- K192183 FDA UDI
- FDA Product Code
- EYB FDA UDI
- GMDN Term
- Ureteral catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ureteral catheter
OlyCath Straight 2 Eye 5 French by Promepla — Class II — 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
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
Cleared under the same submission
K192183 also covers:
- OlyCath Curved 0 Eye 4 French — Promepla
- OlyCath Curved 0 Eye 5 French — Promepla
- OlyCath Curved 0 Eye 6 French — Promepla
- OlyCath Curved 0 Eye 7 French — Promepla
- OlyCath Curved 0 Eye 8 French — Promepla
- OlyCath Straight 0 Eye 4 French — Promepla
- OlyCath Straight 0 Eye 5 French — Promepla
- OlyCath Straight 0 Eye 6 French — Promepla
- OlyCath Straight 0 Eye 7 French — Promepla
- OlyCath Straight 0 Eye 8 French — Promepla
- OlyCath Straight 2 Eye 4 French — Promepla
- OlyCath Straight 2 Eye 6 French — Promepla
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
- Promepla
Sources (1)
- FDA UDI 084d1fb2-cde7-4faf-924e-446ae06ddf06 35 fields · synced Jun 6, 2026