Totalis™ Rigid Endo Kit

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Totalis™ Rigid Endo Kit FDA UDI
Generic Name: Ureteral patency kit FDA UDI
Device Name: Totalis™ Rigid Endo Kit with InLay® VersaFit™ Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire FDA UDI
Model / Reference: REK32N FDA UDI
Description: Totalis™ Rigid Endo Kit with InLay® VersaFit™ Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire FDA UDI

Identifiers

Catalog Number: REK32N FDA UDI
Primary DI / UDI-DI: 00801741097591 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 6 French FDA UDI

Category: Ureteral patency kit

Totalis™ Rigid 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™ Flexible 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 2d457306-ad7f-49bf-8d92-73378d80a457 36 fields · synced May 31, 2026