Proxis™ Ureteral Access Sheath

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Proxis™ Ureteral Access Sheath FDA UDI
Generic Name: Ureteral introduction sheath FDA UDI
Device Name: Proxis™ Ureteral Access Sheath FDA UDI
Model / Reference: 231235 FDA UDI
Description: Proxis™ Ureteral Access Sheath FDA UDI

Identifiers

Catalog Number: 231235 FDA UDI
Primary DI / UDI-DI: 00801741101717 FDA UDI
FDA Product Code: FED FDA UDI
GMDN Term: Ureteral introduction sheath FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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 — 14 French FDA UDI
Length — 35 Centimeter FDA UDI

Category: Ureteral introduction sheath

Proxis™ Ureteral Access Sheath by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ureteral introduction sheath.

Manawa Access Sheath — ENVASTE LTD · Class IIa
Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · 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 b89baff9-f331-47ac-8a5f-2ff63400d131 36 fields · synced May 31, 2026