Salvin OraMem- Sustained™ Duration Absorbable Collagen Membrane #ORAMEMSUS30X40

GUDID 30381780072625

#ORAMEM SUS 30x40 OraMem Sustained absorbable collagen membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. OraMem Sustained absorbable collagen membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achillies) tendon. Bovine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial amounts. The OraMem Sustained membrane is completely absorbable, eliminating the need for the second surgical procedure required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.

Integra Lifesciences Corporation

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, 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 ID30381780072625
NIH Device Record Keyf4ad166a-d2e0-4987-a5b6-1fb7d59c56a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalvin OraMem- Sustained™ Duration Absorbable Collagen Membrane
Version Model Number#ORAMEMSUS30X40
Catalog Number#ORAMEMSUS30X40
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780072621 [Primary]
GS130381780072625 [Package]
Contains: 10381780072621
Package: CAS [12 Units]
In Commercial Distribution
HIBCCM269ORAMEMSUS30X401 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone grafting material, synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2015-09-22

On-Brand Devices [Salvin OraMem- Sustained™ Duration Absorbable Collagen Membrane]

30381780072625#ORAMEM SUS 30x40 OraMem Sustained absorbable collagen membrane is an absorbable, implantable m
30381780072618#ORAMEM SUS 20x30 OraMem Sustained absorbable collagen membrane is an absorbable, implantable m
30381780072601#ORAMEM SUS 15x20 OraMem Sustained absorbable collagen membrane is an absorbable, implantable m
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