CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1 025292

GUDID 03661532002954

CRYO BIO SYSTEM

Tissue cryostorage straw vitrification set

• Primary Device ID: 03661532002954
• NIH Device Record Key: 3b833f88-9edb-4ba3-8a11-158615e2533e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CBS HIGH SECURITY EMBRYO AND SPERM STRAW/5x4x1
• Version Model Number: 1
• Catalog Number: 025292
• 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: false
• Expiration Date: true
• 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	03661532002954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002595

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

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

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
• 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