CRYOLOCK(C)

Basic Information

• Brand Name: CRYOLOCK(C)
• Primary DI: B056CLRCTC1
• Version / Model: CL-R-CT(C)
• Catalog Number: CL-R-CT (Clear)
• Company Name: BIOTECH INCORPORATED
• Labeler DUNS: 080129843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-04-21
• Public Version: 4
• Public Version Date: 2021-05-21
• Public Version Status: Update
• Public Device Record Key: b2288ac5-ad22-4998-8338-c40394764a9e

Device Description

Cryolock - Clear Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47446	Assisted reproduction vitrification carrier	A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B056CLRCTC5	HIBCC	Box	36	In Commercial Distribution
Package	B056CLRCTC2	HIBCC	Pack of 50	10	In Commercial Distribution
Primary	B056CLRCTC1	HIBCC
Unit of Use	B056CLRCTC0	HIBCC
Package	B056CLRCTC3	HIBCC	Pack of 10	2	In Commercial Distribution
Package	B056CLRCTC7	HIBCC	Box of 2000	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K122982	000