VITALA PORCINE DERIVED COLLAGEN MEMBRANES

GUDID D765VIT152010

Resorbable Porcine Derived Collagen Barrier Membrane, 15mm x 20mm, Sterile, Contents: 1 Membrane

Osteogenics Biomedical Inc

Collagen dental regeneration membrane
Primary Device IDD765VIT152010
NIH Device Record Key61e90d3f-abbf-4b74-b384-0e50fce66a4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITALA PORCINE DERIVED COLLAGEN MEMBRANES
Version Model NumberVIT1520-1
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Dimensions

Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter
Length20 Millimeter
Width15 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765VIT152010 [Primary]

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2016-05-02

On-Brand Devices [VITALA PORCINE DERIVED COLLAGEN MEMBRANES]

D765VIT304010Resorbable Porcine Derived Collagen Barrier Membrane, 30mm x 40mm, Sterile, Contents: 1 Membrane
D765VIT203010Resorbable Porcine Derived Collagen Barrier Membrane, 20mm x 30mm, Sterile, Contents: 1 Membrane
D765VIT152010Resorbable Porcine Derived Collagen Barrier Membrane, 15mm x 20mm, Sterile, Contents: 1 Membrane
D765VIT132510Resorbable Porcine Derived Collagen Barrier Membrane, 13mm x 25mm, Sterile, Contents: 1 Membrane
D765VIT101010Resorbable Porcine Derived Collagen Barrier Membrane, 10 mm x 10 mm, Sterile, Contents: 1 Membra

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