← Back to catalogue

Cryolock

FDA UDI

Class II (US FDA UDI)

by Biotech Incorporated

Identity

Trade Name
Cryolock FDA UDI
Generic Name
Assisted reproduction vitrification carrier FDA UDI
Device Name
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos FDA UDI
Model / Reference
CL-R-CT FDA UDI
Description
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos FDA UDI

Identifiers

Catalog Number
CL-R-CT FDA UDI
Primary DI / UDI-DI
B056CLRCT1 FDA UDI
510(k) Number
K122982 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Cryolock by Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K122982 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotech Incorporated

Sources (1)

  • FDA UDI 8c06a91e-65a6-4c69-bf20-0906f9f87d37 37 fields · synced May 31, 2026