GBX Twin Pack

Basic Information

• Brand Name: GBX Twin Pack
• Primary DI: 40889971901855
• Version / Model: GBX Twin Pack
• Catalog Number: 1901859
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2020-06-08
• Public Version Status: Update
• Public Device Record Key: 54b467eb-0675-43c5-8b11-7285000984ea
• Distribution End Date: 2020-06-04

Device Description

GBX Twin Pack - 2x1GL

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWZ	Film, radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41008	X-ray film processing chemical, manual	A chemical, e.g., a fixer or developer, used in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889971901859	GS1	Case	6	Not in Commercial Distribution	2020-06-04
Primary	40889971901855	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius