Salvin OraMEM™ Absorbable Collagen Membrane #ORAMEM30X40

GUDID 30381780072595

ORAMEM 30x40 OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. The OraMem membrane is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbabble membrane. The collage is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.

Integra Lifesciences Corporation

Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental soft-tissue matrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived Dental/maxillofacial soft-tissue biomatrix implant, animal-derived

• Primary Device ID: 30381780072595
• NIH Device Record Key: 3ad91f78-b205-43ea-98d8-83f48a02f4ed
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Salvin OraMEM™ Absorbable Collagen Membrane
• Version Model Number: #ORAMEM30X40
• Catalog Number: #ORAMEM30X40
• 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
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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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072591 [Primary]
GS1	30381780072595 [Package]; Contains: 10381780072591; Package: CAS [12 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution
HIBCC	M269ORAMEM30X401 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924408

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: 6
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [Salvin OraMEM™ Absorbable Collagen Membrane]

• 30381780072595: ORAMEM 30x40 OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabr
• 30381780072588: ORAMEM 20x30 OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabr
• 30381780072571: ORAMEM 15x20 OraMem absorbable collagen membrane is a white, compressed, non-friable matrix fabr