Totalis™ Flexible Endo Kit

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

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: FEK26HW 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: FEK26HW FDA UDI
Primary DI / UDI-DI: 00801741097614 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
Length — 26 Centimeter 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

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Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI 62438eb9-5d48-4ecf-832e-bc800127a559 36 fields · synced Jun 1, 2026