BIOBRANE 66027701

GUDID 05000223504120

BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)

SMITH & NEPHEW MEDICAL LIMITED

Collagen wound matrix dressing

• Primary Device ID: 05000223504120
• NIH Device Record Key: 7769071b-0106-4d3c-898b-227d9d41bb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOBRANE
• Version Model Number: 66027701
• Catalog Number: 66027701
• 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
• 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
• 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: -
• 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: -
• 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	05000223504045 [Primary]
GS1	05000223504120 [Package]; Contains: 05000223504045; Package: CAR [5 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: 2025-03-07
• Device Publish Date: 2025-02-27

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

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• 05000223504120 - BIOBRANE: 2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)
• 05000223402464 - IV3000 6X8CM-CARTON OF 100: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049249 - IV3000 6X8.5CM-CARTON OF 10: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049256 - IV3000: 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10
• 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20: 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad
• 00040565122564 - IODOSORB: 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube
• 05000223500184 - RENASYS: 2023-09-07 Renasys XL Transparent Film Dressing
• 05000223500207 - RENASYS: 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port