SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name: SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray FDA UDI
Generic Name: Indwelling urethral catheterization kit, adult FDA UDI
Device Name: SureStep™ Foley Tray System Lubri-Sil® I.C. Complete Care® Temperature Sensing Foley Catheter Tray FDA UDI
Model / Reference: B319516AM FDA UDI
Description: SureStep™ Foley Tray System Lubri-Sil® I.C. Complete Care® Temperature Sensing Foley Catheter Tray FDA UDI

Identifiers

Catalog Number: B319516AM FDA UDI
Primary DI / UDI-DI: 00801741099717 FDA UDI
FDA Product Code: MJC FDA UDI
EZL FDA UDI
GMDN Term: Indwelling urethral catheterization kit, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 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

Yes

FDA UDI

Combination Product

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 16 French FDA UDI

Category: Indwelling urethral catheterization kit, adult

SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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 9c6711ab-95c6-4a23-bbc2-99912e790b04 36 fields · synced May 30, 2026