X-CEL ANKLE STABILIZER REG

GUDID 00610570090655

Bird & Cronin, LLC

Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis Ankle/foot orthosis

• Primary Device ID: 00610570090655
• NIH Device Record Key: 627da349-3684-4169-a635-a85f3e9c5241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-CEL ANKLE STABILIZER REG
• Version Model Number: 08140704
• Company DUNS: 045975349
• Company Name: Bird & Cronin, 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	00610570090655 [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: 2022-09-07
• Device Publish Date: 2022-08-30

Devices Manufactured by Bird & Cronin, LLC

• 00610570191390 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191406 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191413 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 50610570191418 - B-Cool Chest & AB Binder Wrap: 2023-05-31
• 00610570191451 - B-Cool Super Sling Plus Universal (Complete Set): 2023-02-28
• 00610570191581 - Short Anklizer Low Profile Walker XS: 2023-02-28
• 00610570191598 - Short Anklizer Low Profile Walker Small: 2023-02-28
• 00610570191604 - Short Anklizer Low Profile Walker Medium: 2023-02-28