CBS Non-Sterile High Security Tube 022251

GUDID 03661532002626

CRYO BIO SYSTEM

Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set Tissue cryostorage straw vitrification set

• Primary Device ID: 03661532002626
• NIH Device Record Key: a60b8e99-bf9e-47d0-88af-ba3125b65d52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CBS Non-Sterile High Security Tube
• Version Model Number: 1
• Catalog Number: 022251
• Company DUNS: 500731872
• Company Name: CRYO BIO SYSTEM
• Device Count: 1
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661532002626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002595

FDA Product Code

• MQG: Accessory, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-30

Devices Manufactured by CRYO BIO SYSTEM

• 03661532002077 - STERILE CBS HIGH SECURITY TISSUE 2 ML STRAW / BY 20: 2020-12-15
• 03661532000301 - STERILE CBS 0.3ML STRAW FOR SPERM WITHOUT JACKET WHITE PLUG - 4X5: 2020-11-09
• 03661532000325 - STERILE CBS 0.3 ML STRAW FOR SPERM WITHOUT JACKET WITH WHITE PLUG - 5x20: 2020-11-09
• 03661532000332 - STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20: 2020-11-09
• 03661532002626 - CBS Non-Sterile High Security Tube: 2020-11-09
• 03661532002626 - CBS Non-Sterile High Security Tube: 2020-11-09
• 03661532002633 - CBS STERILE HIGH SECURITY TUBE BY 20 UNITS: 2020-11-09
• 03661532002657 - CBS STERILE HIGH SECURITY TUBE BY 50 UNITS: 2020-11-09
• 03661532002947 - CBS STERILE FILLING NOZZLE - BOX 100: 2020-11-09