Salvin OraMem- Sustained™ Duration Absorbable Collagen Membrane #ORAMEMSUS20X30

GUDID 30381780072618

#ORAMEM SUS 20x30 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 ID30381780072618
NIH Device Record Keyd40c1d35-bb8d-4139-ae9a-5ce7266e5075
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalvin OraMem- Sustained™ Duration Absorbable Collagen Membrane
Version Model Number#ORAMEMSUS20X30
Catalog Number#ORAMEMSUS20X30
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
GS110381780072614 [Primary]
GS130381780072618 [Package]
Contains: 10381780072614
Package: CAS [12 Units]
In Commercial Distribution
HIBCCM269ORAMEMSUS20X301 [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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