← Back to catalogue

Supra-Foley

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
SUPRA-FOLEY FDA UDI
Generic Name
Suprapubic catheter introducer, single-use FDA UDI
Device Name
Suprapubic Catheter Introducer, 12 French FDA UDI
Model / Reference
12Fr Introducer FDA UDI
Description
Suprapubic Catheter Introducer, 12 French FDA UDI

Identifiers

Catalog Number
SF-S12-852 FDA UDI
Primary DI / UDI-DI
H671SFS128520 FDA UDI
510(k) Number
K884061 FDA UDI
FDA Product Code
KOB FDA UDI
GMDN Term
Suprapubic catheter introducer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 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

Dimensions & Sizes

Size
Catheter Gauge — 12 French FDA UDI

Category: Suprapubic catheter introducer, single-use

Supra-Foley by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suprapubic catheter introducer, single-use.

Cleared under the same submission

K884061 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI ee7ccabd-098b-41e4-96f0-a63c1bee3a9f 37 fields · synced Jun 9, 2026