F8X LACER ANKLE W/STAYS LG

GUDID 00840314812308

Hausmann Enterprises, LLC

Ankle/foot orthosis

• Primary Device ID: 00840314812308
• NIH Device Record Key: d785bd49-0e41-4d95-b60c-e3ddd5731b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F8X LACER ANKLE W/STAYS LG
• Version Model Number: HM2534
• Company DUNS: 001892660
• Company Name: Hausmann Enterprises, LLC
• 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: 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	00840314812308 [Primary]

FDA Product Code

• ITW: Joint, Ankle, External Brace

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: 2025-01-10
• Device Publish Date: 2025-01-02

Devices Manufactured by Hausmann Enterprises, LLC

• 00840314812285 - F8X LACER ANKLE W/STAYS SM: 2025-01-10
• 00840314812308 - F8X LACER ANKLE W/STAYS LG: 2025-01-10
• 00840314812308 - F8X LACER ANKLE W/STAYS LG: 2025-01-10
• 00840314811097 - UNIV ARM SLING W/FOAM STRAP ADULT: 2025-01-09
• 00840314811165 - ELASTIC ANKLE SUPPORT SM: 2025-01-09
• 00840314811172 - ELASTIC ANKLE SUPPORT MD: 2025-01-09
• 00840314811189 - ELASTIC ANKLE SUPPORT LG: 2025-01-09
• 00840314811196 - ELASTIC ANKLE SUPPORT XL: 2025-01-09
• 00840314811202 - ELASTIC ELBOW SUPPORT SM: 2025-01-09