Integra® Miltex® HeliMend® Advanced Absorbable Collagen Membrane 62206

GUDID 30381780038515

HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks.

Integra Lifesciences Corporation

General oral wound dressing, animal-derived

• Primary Device ID: 30381780038515
• NIH Device Record Key: c79f94f1-0ee0-435a-b461-f0cbcc5d807a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Miltex® HeliMend® Advanced Absorbable Collagen Membrane
• Version Model Number: 62206
• Catalog Number: 62206
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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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.
• 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.
• 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.
• 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.
• 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.
• 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	10381780038511 [Primary]
GS1	30381780038515 [Package]; Contains: 10381780038511; Package: CAS [12 Units]; In Commercial Distribution
HIBCC	M269622061 [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

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

[30381780038515]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-07
• Device Publish Date: 2015-09-22

On-Brand Devices [Integra® Miltex® HeliMend® Advanced Absorbable Collagen Membrane]

• 30381780038539: HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendo
• 30381780038522: HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendo
• 30381780038515: HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendo