FDA.reportPublic FDA data

Salvin OraMEM™ Absorbable Collagen Membrane

Primary DI
30381780072571
Brand
Salvin OraMEM™ Absorbable Collagen Membrane
Company
Integra Lifesciences Corporation
Model
#ORAMEM15X20
Catalog number
#ORAMEM15X20
Device description
ORAMEM 15x20 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.
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924408000COLLA-TEC ABSORBABLE COLLAGEN MEMBRANEColla-Tec, Inc.1995-08-22LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780072571PackageGS112Not in Commercial Distribution
10381780072577PrimaryGS10
M269ORAMEM15X201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178007257130381780072571
1038178007257710381780072577

GMDN Terms#

Term, Definition table
TermDefinition
Dental soft-tissue matrix implant, animal-derivedA sterile bioabsorbable material intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, primarily through promotion of new blood vessels; it is indicated for various oral soft tissue augmentation procedures (e.g. alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied to soft tissue by properly prepared flaps during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The product should be stored at room temperature. Avoid excessive heat and humidity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10381780374121AccuDrain®SP02202017-05-08
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