Genemed®

Basic Information

• Brand Name: Genemed®
• Primary DI: 00615233007957
• Version / Model: 10-0044
• Catalog Number: 10-0044
• Company Name: SAKURA FINETEK U.S.A., INC.
• Labeler DUNS: 179135769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-12-28
• Public Version: 1
• Public Version Date: 2020-01-06
• Public Version Status: New
• Public Device Record Key: 87de70b3-2154-4f7c-9978-cc6b4d2c9cba

Device Description

PBS Powder

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59119	Phosphate buffer/Sorenson buffer solution IVD	A phosphate buffer or Sorenson buffer solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615233007957	GS1
Unit of Use	00615233006936	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]