CRYOcheck™ Clot C™

Basic Information

• Brand Name: CRYOcheck™ Clot C™
• Primary DI: 00843876000404
• Version / Model: CCC-30
• Company Name: Precision Biologic Inc
• Labeler DUNS: 244713368
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 24450d17-bb38-498b-8341-c7eea8170b83

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55996	Multiple coagulation factor IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.	No	Active
47387	Protein C IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein C in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843876000404	GS1
Unit of Use	00843876010403	GS1

Premarket Submissions

Submission Number	Supplement Number
K040987	000