SpermSelect IUI Kit

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: SpermSelect IUI Kit FDA UDI
Generic Name: Spermatozoa/semen motility medium supplement FDA UDI
Device Name: Contents: One SpermSelect System and one Select IUI FDA UDI
Model / Reference: SM602-F FDA UDI
Description: Contents: One SpermSelect System and one Select IUI FDA UDI

Identifiers

Primary DI / UDI-DI: 60888937003637 FDA UDI
510(k) Number: K900308 FDA UDI
FDA Product Code: HDR FDA UDI
GMDN Term: Spermatozoa/semen motility medium supplement 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

Yes

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: Spermatozoa/semen motility medium supplement

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

Similar devices

Also classified as Spermatozoa/semen motility medium supplement.

Enhance Sperm Wash with Gentamicin — Vitrolife AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class II
Nidacon — Nidacon International AB · Class II
Enhance-S Plus — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class II
Enhance Sperm Wash w/ Gentamicin — Vitrolife AB · Class II
Nidacon — Nidacon International AB · Class I

Cleared under the same submission

K900308 also covers:

Sperm Select System — 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 1778fcb9-49f7-4a8c-84a5-4b76602d063f 34 fields · synced Jun 9, 2026