S-CRYOLOCK (O) S-CL (ORANGE)

GUDID B056SCLO5

S-CRYOLOCK - ORANGE - 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: B056SCLO5
• NIH Device Record Key: 12f93b08-2ca7-44b7-ab60-49c30e991ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-CRYOLOCK (O)
• Version Model Number: S-CL (O)
• Catalog Number: S-CL (ORANGE)
• 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
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• Phone: 1-800-313-7793
• Email: BIOTECH@BIODISENO.COM
• 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	B056SCLO0 [Unit of Use]
HIBCC	B056SCLO1 [Primary]
HIBCC	B056SCLO2 [Package]; Contains: B056SCLO1; Package: PK/50 [10 Units]; In Commercial Distribution
HIBCC	B056SCLO3 [Package]; Contains: B056SCLO1; Package: PK/10 [2 Units]; In Commercial Distribution
HIBCC	B056SCLO5 [Package]; Contains: B056SCLO2; Package: BOX/2000 [40 Units]; 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

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

[B056SCLO5]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-06
• Device Publish Date: 2019-04-26

Devices Manufactured by BIOTECH INCORPORATED

• 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): 2019-05-06S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
• 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