Green RE 400 Speed EHYMD

GUDID 05414904040140

USABS CAS US GREEN 400 8X10I.

AGFA

X-ray film cassette, manual

• Primary Device ID: 05414904040140
• NIH Device Record Key: 1c47a9da-be75-4e04-bb01-38ed2b8200fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Green RE 400 Speed
• Version Model Number: Green RE 400 Speed 8X10
• Catalog Number: EHYMD
• 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: true
• 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

Device Dimensions

• Length: 8 Inch
• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904040140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023020

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: 4
• Public Version Date: 2019-06-14
• Device Publish Date: 2016-09-01

On-Brand Devices [Green RE 400 Speed]

• 05414904040157: USABS CAS US GREEN 400 10X12I.
• 05414904040140: USABS CAS US GREEN 400 8X10I.
• 05414904040126: USABS CAS US GREEN 400 18X43
• 05414904040119: USABS CAS US GREEN 400 24X30
• 05414904040102: USABS CAS US GREEN 400 30X35
• 05414904040096: USABS CAS US GREEN 400 35X43