Identity
- Trade Name
- Totalis™ Flexible Endo Kit FDA UDI
- Generic Name
- Ureteral patency kit FDA UDI
- Device Name
- Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire FDA UDI
- Model / Reference
- FEK32HW FDA UDI
- Description
- Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire FDA UDI
Identifiers
- Catalog Number
- FEK32HW FDA UDI
- Primary DI / UDI-DI
- 00801741097621 FDA UDI
- FDA Product Code
- FAD FDA UDI
- GMDN Term
- Ureteral patency kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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 — 6 French FDA UDI
Category: Ureteral patency kit
Totalis™ Flexible Endo Kit by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral patency kit.
- Totalis™ Rigid Endo Kit — C. R. Bard, Inc. · Class II
- Totalis™ Flexible Endo Kit — C. R. Bard, Inc. · Class II
- Totalis™ Flexible Endo Kit — C. R. Bard, Inc. · Class II
- Totalis™ Rigid Endo Kit — C. R. Bard, Inc. · Class II
- Totalis™ Rigid Endo Kit — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 67e55f57-362a-44e8-a2a1-2c5989feb243 36 fields · synced May 30, 2026