SURGISCREEN

Basic Information

• Brand Name: SURGISCREEN
• Primary DI: 10758750007660
• Version / Model: 6902316
• Catalog Number: 6902316
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Labeler DUNS: 068715424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-22
• Public Version: 6
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 922f5ab3-85c2-48ef-a135-39174170e295

Device Description

0.8% SURGISCREEN 3X10ML

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
52544	Antibody screening reagent red blood cell IVD, kit, agglutination	A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750007660	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius