Mamoray HDR-C Plus EMG8K

GUDID 05414904225066

AGFA

Medical x-ray film, screen

• Primary Device ID: 05414904225066
• NIH Device Record Key: d1eb744c-eece-4df2-aaef-d38c402733b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mamoray HDR-C Plus
• Version Model Number: MAMORAY HDR-C PLUS 18x24
• Catalog Number: EMG8K
• Company DUNS: 374444883
• Company Name: AGFA
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter
• Length: 18 Centimeter
• Width: 24 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904009901 [Primary]
GS1	05414904225059 [Unit of Use]
GS1	05414904225066 [Package]; Contains: 05414904009901; Package: [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: 2022-11-24
• Device Publish Date: 2022-11-16

Devices Manufactured by AGFA

• 05414904271124 - SE Suite: 2023-10-18 Software
• 05414904208168 - NX 3.0: 2023-07-26
• 05414904233320 - NX 4.0: 2023-07-26
• 05414904281321 - DR 400: 2023-03-31
• 05414904225066 - Mamoray HDR-C Plus: 2022-11-24
• 05414904225066 - Mamoray HDR-C Plus: 2022-11-24
• 05414904231678 - Dentus M2 Comfort: 2022-11-24
• 05414904231692 - Dentus M2 Comfort: 2022-11-24
• 05414904231531 - Dentus Ortholux Register: 2022-11-14