Cryotop US(W)

FDA UDI

Class II (US FDA UDI)

by Kitazato Corporation

Identity

Trade Name: Cryotop US(W) FDA UDI
Generic Name: Assisted reproduction vitrification carrier FDA UDI
Model / Reference: Cryotop US(W) FDA UDI

Identifiers

Catalog Number: 81173 FDA UDI
Primary DI / UDI-DI: 04582231462919 FDA UDI
510(k) Number: K153027 FDA UDI
FDA Product Code: MQK FDA UDI
GMDN Term: Assisted reproduction vitrification carrier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6160 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 vitrification carrier

Cryotop US(W) by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CRYOPETTE — ORIGIO INC. · Class II

Cleared under the same submission

K153027 also covers:

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: Kitazato Corporation

Sources (1)

FDA UDI 03e6f15b-54a1-48f4-97b4-f3485fa0d8d0 34 fields · synced Jun 1, 2026