Gafchromic™ 969971

GUDID 00850000065574

ASHLAND SPECIALTY INGREDIENTS G.P.

Medical x-ray film, non-screen

• Primary Device ID: 00850000065574
• NIH Device Record Key: 0d487990-0779-4dae-8dd2-0a5008d3d62a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gafchromic™
• Version Model Number: EBT-XD MAX-HD 2.0 @35SH
• Catalog Number: 969971
• Company DUNS: 152728887
• Company Name: ASHLAND SPECIALTY INGREDIENTS G.P.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000065574 [Primary]

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: 2022-09-14
• Device Publish Date: 2022-09-06

On-Brand Devices [Gafchromic™]

• 00850000065611: EBT3 MX-HD BLCK-2D ANT
• 00850000065963: Blood Irradiation Indicator
• 00850000065956: Blood Irradiation Indicator
• 00850000065949: Blood Irradiation Indicator
• 00850000065932: Blood Irradiation Indicator
• 00850000065925: Blood Irradiation Indicator
• 00850000065918: Blood Irradiation Indicator
• 00850000065895: Blood Irradiation Indicator
• 00850000065888: Blood Irradiation Indicator
• 00850000065857: Blood Irradiation Indicator
• 00850000065840: Blood Irradiation Indicator
• 00850000065833: Blood Irradiation Indicator
• 00850000065826: Blood Irradiation Indicator
• 00850000065796: Blood Irradiation Indicator
• 00850000065789: Blood Irradiation Indicator
• 00850000065994: EBT3 Lateral Film Block @30SH
• 00850000065987: EBT3 Baby Blue Phantom @30SH
• 00850000065970: EBT3 Thorax Phantom Film @22SH
• 00850000065871: HD-V2 2X2.5 @50SH
• 00850000065864: EBT3 2 X 2.5 @50SH
• 00850000065772: EBT-XD MAX-EI @20SH
• 00850000065765: EBT3 MAX-EI @20SH
• 00850000065758: EBT-XD DP-850 @20SH
• 00850000065741: EBT3 DP-850 @20SH
• 00850000065734: XRSP2 4x2.5 @20SH
• 00850000065727: RTQA2 Calibration Strip @50SH
• 00850000065710: EBT3 Calibration Strip @50SH
• 00850000065703: XRQA2 Calibration Strip @50SH
• 00850000065697: MD-V3 Calibration Strip @50SH
• 00850000065680: HD-V2 Calibration Strip @50SH
• 00850000065673: EBT-XD Calibration Strip @50SH
• 00850000065666: XR-SP2 8x10
• 00850000065659: XR-SP2 10x12
• 00850000065642: EBT XD Custom 7.5 X 6 @50SH
• 00850000065628: EBT-XD 1X1CM @20SH
• 00850000065604: EBT-XD DP-1000 @20SH
• 00850000065598: EBT3 DP-1000 @20SH
• 00850000065581: EBT3 IMT CAL STRIP @25SH
• 00850000065574: EBT-XD MAX-HD 2.0 @35SH
• 00850000065567: EBT3 MAX-HD 2.0 @35SH
• 00850000065550: EBT3 3X3 @60SH
• 00850000065543: EBT3 Ballcube II w/o slit @32SH
• 00850000065536: EBT-XD Ballcube II w/o slit @32SH
• 00850000065529: EBT-XD MX-HD BLCK-2D ANT @50SH
• 00850000065512: EBT-XD CAL STRIP MX-HD @25SH
• 00850000065505: RTQA2 10x10P @25SH
• 00850000065499: EBT3 Phantom 8X10 @25 SH
• 00850000065475: MD-V3 8x10 @10SH
• 00850000065468: EBT3 15X15CM @25 SH
• 00850000065451: HD-V2 8x10 @10SH