CR MD4.0 GENERAL CASSETTE 37PSM

GUDID 05414904028995

CR MD4.0 GENERAL CASS SR 35X43

AGFA

Digital imaging cassette

• Primary Device ID: 05414904028995
• NIH Device Record Key: 335a8d12-06cb-48e6-9ba5-85f3c5d844d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR MD4.0 GENERAL CASSETTE
• Version Model Number: CR MD4.0 GENERAL CASSETTE 35X43
• Catalog Number: 37PSM
• Company DUNS: 374444883
• Company Name: AGFA
• 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: true
• 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

Customer Support Contacts

• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Dimensions

• Length: 35 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter
• Width: 43 Centimeter
• Length: 35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904028995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041701

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

On-Brand Devices [CR MD4.0 GENERAL CASSETTE]

• 05414904038840: CR MD4.0 GEN CASS PS ASYM 35X43
• 05414904029220: CR MD4.0 GENERAL CASS HR 15X30
• 05414904029213: CR MD4.0 GENERAL CASS HR 18X24
• 05414904029206: CR MD4.0 GENERAL CASS HR 24X30
• 05414904029039: CR MD4.0 GEN CASS PS SYM 35X43
• 05414904029022: CR MD4.0 GENERAL CASS HR 35X35
• 05414904029015: CR MD4.0 GENERAL CASS SR 35X35
• 05414904029008: CR MD4.0 GENERAL CASS HR 35X43
• 05414904028995: CR MD4.0 GENERAL CASS SR 35X43
• 05414904028988: CR MD4.0 GENERAL CASS HR 10X12I
• 05414904028971: CR MD4.0 GENERAL CASS HR 8X10I