Catheter Stabilization Device

FDA UDI

Class I (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: Catheter Stabilization Device FDA UDI
Generic Name: Urinary catheter holder FDA UDI
Device Name: StatLock 2-way Foley Stabilization Devices, Catheter Stabilization Devices, 2-way Foley Stabilitzation device. Includes: skin prep pad FDA UDI
Model / Reference: FOL0101 FDA UDI
Description: StatLock 2-way Foley Stabilization Devices, Catheter Stabilization Devices, 2-way Foley Stabilitzation device. Includes: skin prep pad FDA UDI

Identifiers

Catalog Number: FOL0101 FDA UDI
Primary DI / UDI-DI: 00801741076091 FDA UDI
FDA Product Code: EYJ FDA UDI
GMDN Term: Urinary catheter holder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urinary catheter holder

Catheter Stabilization Device by C. R. Bard, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Urinary catheter holder.

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Urocare® Fabric Foley® Catheter/Tubing Strap Arm 14" — UROCARE PRODUCTS, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: C. R. Bard, Inc.

Sources (1)

FDA UDI 0f15772c-0c6f-4489-a708-84c644a4c62c 36 fields · synced May 30, 2026