DRYSTAR DT 2 B EKMEY

GUDID 05414904225486

AGFA

Medical printer film Medical printer film Medical printer film Medical printer film Medical printer film

• Primary Device ID: 05414904225486
• NIH Device Record Key: 2d5c4752-a46c-4603-a47c-54e8f063a527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRYSTAR DT 2 B
• Version Model Number: DRYSTAR DT 2 B 25 x 30
• Catalog Number: EKMEY
• 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

Device Dimensions

• Width: 30 Centimeter
• Length: 25 Centimeter
• Width: 30 Centimeter
• Length: 25 Centimeter
• Width: 30 Centimeter
• Length: 25 Centimeter
• Width: 30 Centimeter
• Length: 25 Centimeter
• Width: 30 Centimeter
• Length: 25 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).
• 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).
• 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).
• 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).
• 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).

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904030431 [Primary]
GS1	05414904225479 [Unit of Use]
GS1	05414904225486 [Package]; Contains: 05414904030431; 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: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [DRYSTAR DT 2 B]

• 05414904225509: DRYSTAR DT 2 B 20 x 25
• 05414904225400: DRYSTAR DT 2 B 35 x 43
• 05414904225424: DRYSTAR DT 2 B 28 x 35
• 05414904225486: DRYSTAR DT 2 B 25 x 30