VITALA PORCINE DERIVED COLLAGEN MEMBRANES

GUDID D765VIT101010

Resorbable Porcine Derived Collagen Barrier Membrane, 10 mm x 10 mm, Sterile, Contents: 1 Membrane

Osteogenics Biomedical Inc

Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane
Primary Device IDD765VIT101010
NIH Device Record Keydecbab86-d9e0-4750-9bb0-e55375495084
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITALA PORCINE DERIVED COLLAGEN MEMBRANES
Version Model NumberVIT1010-1
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
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

Device Dimensions

Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter
Length10 Millimeter
Width10 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765VIT101010 [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 Number2
Public Version Date2022-05-02
Device Publish Date2018-11-14

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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