CRYOcheck™ Clot S™

GUDID 00843876000428

Precision Biologic Inc

Protein S IVD, kit, clotting

• Primary Device ID: 00843876000428
• NIH Device Record Key: d724bd86-fac7-4f1e-aa79-c9a1f94fd278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ Clot S™
• Version Model Number: CCS-30
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	00843876000428 [Primary]
GS1	00843876010427 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043571

FDA Product Code

• GGP: Test, Qualitative And Quantitative Factor Deficiency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [CRYOcheck™ Clot S™]

• 00843876000428: CCS-30
• 00843876000411: CCS-15