Huestis Medical Flexi-Holder

GUDID 00850077007125

Flexi-Holder GE W/Artic 36" Arm, Huestis Part # FH410-GE-1

HUESTIS MACHINE CORPORATION

X-ray film cassette holder

• Primary Device ID: 00850077007125
• NIH Device Record Key: bebab768-b01b-4eb1-babb-14df3ebf0386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huestis Medical Flexi-Holder
• Version Model Number: FH410-GE-1
• Company DUNS: 001188390
• Company Name: HUESTIS MACHINE CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077007125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792721

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-01

On-Brand Devices [Huestis Medical Flexi-Holder]

• 00085007700701: Flexi-Holder 26" Short Arm, Huestis Part # FH303
• 00850077007125: Flexi-Holder GE W/Artic 36" Arm, Huestis Part # FH410-GE-1
• 00850077007101: Flexi-Holder W/Artic 36" Arm, Huestis Part # FH410-1
• 00850077007095: Flexi-Holder W/Artic 26" Arm, Huestis Part # FH410
• 00850077007088: Flexi-Holder 36" Long Arm, Huestis Part # FH303-1
• 00850077007071: Flexi-Holder 26" Short Arm, Huestis Part # FH303
• 00850077007040: Flexi-Holder W/Artic 26 Arm, (Huestis Part # FH410-GE), (GEHC Part # E6314J)