Neogen Collagen Flex L 64052

GUDID 00813954026008

Resorbable Collagen Dental Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00813954026008
NIH Device Record Keyf56ec2a2-8716-42de-8f88-af09fd8012a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeogen Collagen Flex L
Version Model Number64052
Catalog Number64052
Company DUNS176262442
Company NameCOLLAGEN MATRIX, 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

Customer Support Contacts

Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com
Phone+1 8666263677
Emailmarketingusa@neoss.com

Device Dimensions

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Operating and Storage Conditions

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954026008 [Primary]
GS105060440334153 [Previous]

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 Date2023-09-25
Device Publish Date2023-09-15

Devices Manufactured by COLLAGEN MATRIX, INC.

00813954026497 - CollaShield Extend2024-12-05 Long Term Collagen Membrane
00813954026503 - CollaShield Extend2024-12-05 Long Term Collagen Membrane
00813954026510 - CollaShield Extend2024-12-05 Long Term Collagen Membrane
00813954026022 - RejuvaKnee2024-11-12 Collagen Meniscus Implant
00813954026039 - RejuvaKnee2024-11-12 Collagen Meniscus Implant
00813954026398 - Stylos BA | Putty2024-11-08 Bioactive Glass Matrix
00813954026404 - Stylos BA | Putty2024-11-08 Bioactive Glass Matrix
00813954026411 - Stylos BA | Putty2024-11-08 Bioactive Glass Matrix

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