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McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
CATHETER, FOLEY STRAIGHT TIP SILICONE 16" 18FR 5-10CC FDA UDI
Model / Reference
16-SFOL518 FDA UDI
Description
CATHETER, FOLEY STRAIGHT TIP SILICONE 16" 18FR 5-10CC FDA UDI

Identifiers

Primary DI / UDI-DI
10612479245362 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI 926b1b7e-f016-4c45-bc97-0eed4c996093 33 fields · synced Jun 8, 2026