DIRECTVIEW CR Long-Length Cassette with PQ Screen 8010035

GUDID 60889978010035

DV CR LONG-LENGTH CASS PKG W/ PQ

CARESTREAM HEALTH, INC.

Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray

• Primary Device ID: 60889978010035
• NIH Device Record Key: 165a160e-3421-4fe2-8cfd-eeb3f07d6826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECTVIEW CR Long-Length Cassette with PQ Screen
• Version Model Number: DIRECTVIEW CR Long-Length Cassette with PQ Screen
• Catalog Number: 8010035
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978010035 [Primary]

FDA Product Code

• EAM: Screen, intensifying, radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-14
• Device Publish Date: 2016-09-16

On-Brand Devices [DIRECTVIEW CR Long-Length Cassette with PQ Screen]

• 60889978754144: CR LONG LENGTH PORTABLE CASS W/PQ
• 60889978010035: DV CR LONG-LENGTH CASS PKG W/ PQ
• 60889971033574: CR LLI W/PQ SCREEN