Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040059446
• Version / Model: 9004454
• Catalog Number: 9004454
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2019-02-13
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 5c945367-d6d1-4b78-aa6a-f9f43b597cfe

Device Description

RETREAT HEMOSTATIC GEL SQ

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	CORD, RETRACTION	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
30595	Multiple coagulation factor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20304040059443	GS1		25	In Commercial Distribution
Primary	10304040059446	GS1
Unit of Use	00304040059449	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 29 Degrees Celsius