X-Trans™ HB-1 Armboard 8002041

GUDID 10841962109625

X-Trans Armboards: HB-1 Armboard

Qfix

Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner Radiological arm/leg positioner

• Primary Device ID: 10841962109625
• NIH Device Record Key: a25136c3-b0d7-449c-a685-73db678d6fe8
• Commercial Distribution Discontinuation: 2017-03-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: X-Trans™ HB-1 Armboard
• Version Model Number: 8002041
• Catalog Number: 8002041
• Company DUNS: 808875397
• Company Name: Qfix
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962109625 [Primary]

FDA Product Code

• GDC: TABLE, OPERATING-ROOM, ELECTRICAL

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: 2023-12-11
• Device Publish Date: 2016-12-22

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