S-CRYOLOCK (PK)

Basic Information

• Brand Name: S-CRYOLOCK (PK)
• Primary DI: B056SCLPK1
• Version / Model: S-CL (PK)
• Catalog Number: S-CL (PINK)
• Company Name: BIOTECH INCORPORATED
• Labeler DUNS: 080129843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-10-27
• Public Version: 1
• Public Version Date: 2025-11-04
• Public Version Status: New
• Public Device Record Key: c4b1b383-c3c6-49bb-8034-2f0303d265c0

Device Description

S-CRYOLOCK - PINK - 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	B056SCLPK2	HIBCC	PK/50	10	In Commercial Distribution
Primary	B056SCLPK1	HIBCC
Package	B056SCLPK3	HIBCC	PK/10	2	In Commercial Distribution
Package	B056SCLPK5	HIBCC	BOX/2000	40	In Commercial Distribution
Unit of Use	B056SCLPK0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122982	000