ORACOTE® Absorbable Collagen Wound Dressing for Dental Surgery #ORACOTE-PKG-10

GUDID 30381780000314

SALVIN OraCOTE® Absorbable Collagen Wound Dressing for Dental Surgery, 3/4in x 1 1/2in

Integra Lifesciences Corporation

Collagen wound matrix dressing

• Primary Device ID: 30381780000314
• NIH Device Record Key: f0393dc7-8f04-4c72-8b5a-1b3507885be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORACOTE® Absorbable Collagen Wound Dressing for Dental Surgery
• Version Model Number: #ORACOTE-PKG-10
• Catalog Number: #ORACOTE-PKG-10
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 10
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

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• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
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• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780000313 [Unit of Use]
GS1	10381780000310 [Primary]
GS1	30381780000314 [Package]; Contains: 10381780000310; Package: Case [4 Units]; In Commercial Distribution
HIBCC	M268ORACOTEPKG101 [Secondary]

FDA Product Code

• LPG: Material, Dressing, Surgical, Polylactic Acid

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: 2020-05-06
• Device Publish Date: 2014-09-11

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