CARESTREAM CR Cassette 8198939

GUDID 60889978198931

CARESTREAM CR CASSETTE 35X35/14X14

CARESTREAM HEALTH, INC.

Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette

• Primary Device ID: 60889978198931
• NIH Device Record Key: 28bc04d1-f53a-466f-a012-ad376582ebb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM CR Cassette
• Version Model Number: CR Cassettes for Vita Systems
• Catalog Number: 8198939
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	40889978198937 [Primary]
GS1	60889978198931 [Package]; Contains: 40889978198937; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• IWZ: Film, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-21
• Device Publish Date: 2021-07-13

Devices Manufactured by CARESTREAM HEALTH, INC.

• 60889978625925 - Carestream DRX-1 System: 2023-07-31 DRX-1 SYSTEM CONSOLE UPGRADE
• 60889978624768 - DRX-Compass X-ray System: 2023-07-06 XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
• 00889978626487 - D-Speed: 2023-07-04 100PKT FLASH D-SPEED PERFECT FLM SIZE2
• 60889978818891 - Ultra-speed: 2023-07-04 ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L
• 60889976554104 - CARESTREAM DR Long Length Imaging Stand: 2023-07-04 STEP STOOL FOR LLI
• 60889975950600 - Focus HD 35 Detector: 2023-07-03 FOCUS HD 35 DETECTOR PACK ROK
• 60889975950617 - Focus HD 43 Detector: 2023-07-03 FOCUS HD 43 DETECTOR PACK ROK
• 60889978626007 - DRX-Rise Mobile X-ray System: 2023-06-30 DRX-RISE MOBILE X-RAY SYSTEM