OsseoGuard Flex OGF2030

GUDID 00813954027401

Resorbable Collagen Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00813954027401
NIH Device Record Key05bd1836-fd75-4e2b-ab83-3cbfc0b7c175
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsseoGuard Flex
Version Model NumberOGF2030
Catalog NumberOGF2030
Company DUNS176262442
Company NameCOLLAGEN MATRIX, 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

Customer Support Contacts

Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com
Phone1 561 776 6700
EmailDentalCS@zimvie.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954020365 [Previous]
GS100813954027401 [Primary]

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

On-Brand Devices [OsseoGuard Flex]

00813954020372Resorbable Collagen Membrane for Dental Surgery 30mm x 40mm
00813954020365Resorbable Collagen Membrane for Dental Surgery 20mm x 30mm
00813954020358Resorbable Collagen Membrane for Dental Surgery 15mm x 20mm
00813954027418Resorbable Collagen Membrane
00813954027401Resorbable Collagen Membrane
00813954027395Resorbable Collagen Membrane

Trademark Results [OsseoGuard Flex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSEOGUARD FLEX
OSSEOGUARD FLEX
77956177 4080633 Live/Registered
Biomet 3i, LLC
2010-03-11

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