Cryolock CL-R-CT

GUDID B056CLRCT2

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

BIOTECH INCORPORATED

Assisted reproduction vitrification carrier

• Primary Device ID: B056CLRCT2
• NIH Device Record Key: 8c06a91e-65a6-4c69-bf20-0906f9f87d37
• Commercial Distribution Discontinuation: 2019-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cryolock
• Version Model Number: CL-R-CT
• Catalog Number: CL-R-CT
• Company DUNS: 080129843
• Company Name: BIOTECH INCORPORATED
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-313-7793
• Email: biotech@biodiseno.com
• Phone: 1-800-313-7793
• Email: biotech@biodiseno.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B056CLRCT0 [Unit of Use]
HIBCC	B056CLRCT1 [Primary]
HIBCC	B056CLRCT2 [Package]; Contains: B056CLRCT1; Package: Pack of 50 [10 Units]; Discontinued: 2019-06-01; Not in Commercial Distribution
HIBCC	B056CLRCT5 [Package]; Package: BOX [36 Units]; Discontinued: 2019-06-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122982

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B056CLRCT2]

Radiation Sterilization

[B056CLRCT2]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-03
• Device Publish Date: 2016-12-13

Devices Manufactured by BIOTECH INCORPORATED

• B056CLRCT2 - Cryolock: 2019-06-03Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
• B056CLRCT2 - Cryolock: 2019-06-03 Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage
• B056SCLB5 - S-CRYOLOCK (B): 2019-05-06 S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain
• B056SCLC5 - S-CRYOLOCK (C): 2019-05-06 S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintai
• B056SCLG5 - S-CRYOLOCK (G): 2019-05-06 S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintai
• B056SCLO5 - S-CRYOLOCK (O): 2019-05-06 S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and mainta
• B056SCLY5 - S-CRYOLOCK (Y): 2019-05-06 S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and mainta
• B056CLRCTB2 - Cryolock(B): 2018-07-06 Cryolock - Blue Cryopreservation Storage Device that is intended for use in vitrification procedures to contain and maintain hum
• B056CLRCTC5 - CRYOLOCK(C): 2018-07-06 Cryolock - Clear Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain hu