BioBrace BBXA

GUDID 30653405990707

BioBrace Extra-Articular Ligament Augmentation Kit

Conmed Corporation

General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 30653405990707
• NIH Device Record Key: df885345-cc84-4708-84e0-5d2466428bc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBrace
• Version Model Number: BBXA
• Catalog Number: BBXA
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	20653405990700 [Primary]
GS1	30653405990707 [Package]; Contains: 20653405990700; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252946

FDA Product Code

• OWW: Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-11-25
• Device Publish Date: 2025-10-28

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• 30653405990707: BioBrace Extra-Articular Ligament Augmentation Kit