BioMend® Extend™ Absorbable Collagen Membrane 0141

GUDID 30381780070768

BIOMEND EXTEND 20MM X 30MM (0141) BioMend Extend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue generation procedures in periodontal defects to enhance regeneration of periodontal apparatus. The BioMend Extend membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon.

Integra Lifesciences Corporation

Collagen dental regeneration membrane

• Primary Device ID: 30381780070768
• NIH Device Record Key: 777be4d8-2599-4899-80c7-92f8d55a7116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioMend® Extend™ Absorbable Collagen Membrane
• Version Model Number: 0141
• Catalog Number: 0141
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *The product should be stored at room temperature. Avoid excessive heat and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780070764 [Primary]
GS1	30381780070768 [Package]; Contains: 10381780070764; Package: CAS [12 Units]; In Commercial Distribution
HIBCC	M26921820000201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992216

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [BioMend® Extend™ Absorbable Collagen Membrane]

• 30381780070782: BIOMEND EXTEND 30MM X 40MM (0142) BioMend Extend Absorbable Collagen Membrane is an absorbable,
• 30381780070768: BIOMEND EXTEND 20MM X 30MM (0141) BioMend Extend Absorbable Collagen Membrane is an absorbable,
• 30381780070744: BIOMEND EXTEND 15MM X 20MM (0140) BioMend Extend Absorbable Collagen Membrane is an absorbable,