AccessGUDID - DEVICE: Cryolock (B056CLRCT1)

GUDID

Device Identifier (DI) Information

Brand Name: Cryolock
Version or Model: CL-R-CT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CL-R-CT
Company Name: BIOTECH INCORPORATED

Primary DI Number: B056CLRCT1
Issuing Agency: HIBCC
Commercial Distribution End Date: June 01, 2019
Device Count: 5
Labeler D-U-N-S® Number*: 080129843 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122982	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c06a91e-65a6-4c69-bf20-0906f9f87d37
Public Version Date: June 03, 2019
Public Version Number: 4
DI Record Publish Date: December 13, 2016