TVUS/HSG-Cath

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name: TVUS/HSG-Cath FDA UDI
Generic Name: Intrauterine imaging medium catheter FDA UDI
Device Name: Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer FDA UDI
Model / Reference: Peel-Away Introducer FDA UDI
Description: Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer FDA UDI

Identifiers

Catalog Number: MIS-50P FDA UDI
Primary DI / UDI-DI: H671MIS50P0 FDA UDI
510(k) Number: K063611 FDA UDI
FDA Product Code: LKF FDA UDI
GMDN Term: Intrauterine imaging medium catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 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 — 5 French FDA UDI
Length — 30 Centimeter FDA UDI

Category: Intrauterine imaging medium catheter

TVUS/HSG-Cath by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intrauterine imaging medium catheter.

Cook — COOK INCORPORATED · Class II
uVue — COOK INCORPORATED · Class II
Rocket — Rocket Medical Plc
Rocket — Rocket Medical Plc
Rocket — Rocket Medical Plc · Class II
Batrik H/S Catheter TM 5F — Batrik Medical Manufacturing Inc · Class II
Rocket — Rocket Medical Plc
Cook — COOK INCORPORATED · Class I

Cleared under the same submission

K063611 also covers:

TVUS/HSG-Cath — Utah Medical Products, Inc.

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: Utah Medical Products, Inc.

Sources (1)

FDA UDI 344fc012-90e2-43b5-8cc6-39391a2d38d2 37 fields · synced Jun 9, 2026