Select IUI

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Select IUI FDA UDI
Generic Name: Assisted reproduction transfer catheter/set FDA UDI
Device Name: Intrauterine Insemination Catheter FDA UDI
Model / Reference: SM400 FDA UDI
Description: Intrauterine Insemination Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937003598 FDA UDI
510(k) Number: K954099 FDA UDI
FDA Product Code: MFD FDA UDI
GMDN Term: Assisted reproduction transfer catheter/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5250 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

Category: Assisted reproduction transfer catheter/set

Select IUI by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction transfer catheter/set.

FRYDMAN® CLASSIC 4.5 — LABORATOIRE CCD · Class II
STANDARD INTRA UTERINE INSIMINATION CANNULA — LABORATOIRE CCD · Class II
VitaVitro — Shenzhen Vitavitro Bio-Tech Co., Ltd. · Class II
Trackable Intra Uterine Insemination Catheter Open Tip — ALLWIN MEDICAL DEVICES, INC. · Class II
Kitazato ET Catheter — KITAZATO CORPORATION · Class II
Kitazato ET Catheter — KITAZATO CORPORATION · Class II
Labotect — Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung · Class II
INVENTCATH ECO — LABORATOIRE CCD · Class II

Cleared under the same submission

K954099 also covers:

MiniSpace — CooperSurgical, 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: CooperSurgical, Inc.

Sources (1)

FDA UDI 690e7663-f5d3-4b17-9ef1-426ef5b735cc 34 fields · synced Jun 9, 2026