CryoTip®

FDA UDI

Class II (US FDA UDI)

by Fujifilm Irvine Scientific, Inc.

Identity

Trade Name: CryoTip® FDA UDI
Generic Name: Assisted reproduction cryotube FDA UDI
Device Name: CryoTip FDA UDI
Model / Reference: 40709-Pack FDA UDI
Description: CryoTip FDA UDI

Identifiers

Catalog Number: 40709 FDA UDI
Primary DI / UDI-DI: 00893727002118 FDA UDI
510(k) Number: K041562 FDA UDI
FDA Product Code: MQH FDA UDI
GMDN Term: Assisted reproduction cryotube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6130 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Assisted reproduction cryotube

CryoTip® by Fujifilm Irvine Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fujifilm Irvine Scientific, Inc.

Sources (1)

FDA UDI 8d687168-1a9d-41ca-b440-af402a56e51e 37 fields · synced May 31, 2026