BIOBRANE 66027702

GUDID 05000223504137

BIOBRANE DRESSING 9.8INX15IN CTN 1 US

SMITH & NEPHEW MEDICAL LIMITED

Collagen wound matrix dressing

• Primary Device ID: 05000223504137
• NIH Device Record Key: 2de3192b-ee8c-4508-8ea5-22e47be9d24f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOBRANE
• Version Model Number: 66027702
• Catalog Number: 66027702
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature: -
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight: -
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature: -
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight: -
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature: -
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight: -
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature: -
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight: -
• Special Storage Condition, Specify: Between 0 and 0 *Upper limit of temperature: -
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223504052 [Primary]
GS1	05000223504137 [Package]; Contains: 05000223504052; Package: CAR [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242146

FDA Product Code

• KGN: Wound dressing with animal-derived material(s)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [BIOBRANE]

• 05000223504120: BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)
• 05000223504144: BIOBRANE DRESSING 15INX19.7IN CTN 1 US
• 05000223504137: BIOBRANE DRESSING 9.8INX15IN CTN 1 US
• 05000223504113: BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US