Medical X-ray Cassette with Green 400 Screens 6807085

GUDID 60889976807088

13X18CM MX CASS W/GREEN 400 SCREEN

CARESTREAM HEALTH, INC.

Medical x-ray film, screen

• Primary Device ID: 60889976807088
• NIH Device Record Key: b9b0c44c-4fb7-4733-8dc3-414d541f869f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical X-ray Cassette with Green 400 Screens
• Version Model Number: Medical X-ray Cassette with Green 400 Screens
• Catalog Number: 6807085
• 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	40889976807084 [Primary]
GS1	60889976807088 [Package]; Contains: 40889976807084; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896708

FDA Product Code

• IXA: Cassette, radiographic film

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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Medical X-ray Cassette with Green 400 Screens]

• 60889976807125: 11X14IN MX CASS E/GREEN 400 SCREEN
• 60889976807101: 10X12IN MX CASS W/GREEN 400 SCREEN
• 60889976807095: 8X10IN MX CASS W/GREEN 400 SCREEN
• 60889976807088: 13X18CM MX CASS W/GREEN 400 SCREEN
• 60889976807071: 35X43CM MX CASS W/GRN 400 SCREEN
• 60889976807064: 35X35CM MX CASS W/GRN 400 SCREEN
• 60889976807033: 24X30CM MX CASS W/GRN 400 SCREEN
• 60889976807002: 18X24CM MX CASS W/GREEN 400 SCREEN
• 60889976805770: 35X43CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805763: 35X35CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805756: 30X40CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805732: 24X30CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805718: 18X43CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805701: 18X24CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805695: 15X40CM MXCASS W/GRN400 SCRN W/WNDW
• 60889976805664: 11X14IN MXCASS W/GRN400 SCRN W/WNDW
• 60889976805657: 10X12IN MX CASS W/GRN 400SCRN W/WNDW
• 60889976805640: 8X10IN MX CASS W/GRN 400SCRN W/WNDW