INSIGHT Thoracic Film

Basic Information

• Brand Name: INSIGHT Thoracic Film
• Primary DI: 40889978288201
• Version / Model: INSIGHT Thoracic Film
• Catalog Number: 8288201
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2021-11-08
• Public Version Status: Update
• Public Device Record Key: 777fe0bb-6528-431e-9138-fb7d7ad2516f
• Distribution End Date: 2021-11-02

Device Description

INSIGHT THORACIC FILM 35X43-14X17 100SH

Device Characteristics

• Single Use: Yes
• 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
40979	Medical x-ray film, screen	A screen x-ray film specifically designed for medical diagnostic imaging applications. It is sensitive primarily to wavelengths of light emitted from an image intensifying screen or other visible light source. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. This film is not limited to use with x-ray imaging systems but can also be used in a variety of diagnostic imaging modalities using image intensifier technology or matrix formatters to output images, e.g., nuclear medicine or ultrasound.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889978288205	GS1	Case	5	Not in Commercial Distribution	2021-11-02
Primary	40889978288201	GS1
Unit of Use	00889978288203	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity