Neogen Collagen Firm S 64055

GUDID 00813954025957

Resorbable Collagen Dental Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00813954025957
NIH Device Record Keyc0c2677a-6459-4b33-aa8c-753dda19594a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeogen Collagen Firm S
Version Model Number64055
Catalog Number64055
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 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com
Phone+1 8662623677
Emailmarketingusa@neoss.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
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
GS100813954025957 [Primary]
GS105060440334160 [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.

00813954026268 - OssiMend® Bioactive | Putty2024-09-24 Moldable Bone Graft Matrix
00813954026275 - OssiMend® Bioactive | Putty2024-09-24 Moldable Bone Graft Matrix
00813954026282 - OssiMend® Bioactive | Putty2024-09-24 Moldable Bone Graft Matrix
00813954026299 - OssiMend® Bioactive | Putty2024-09-24 Moldable Bone Graft Matrix
00813954026305 - OssiMend® Bioactive | Puck2024-09-24 Moldable Bone Graft Matrix
00813954026312 - OssiMend® Bioactive | Puck2024-09-24 Moldable Bone Graft Matrix
00813954026329 - OssiMend® Bioactive | Strip2024-09-24 Moldable Bone Graft Matrix
00813954026336 - OssiMend® Bioactive | Strip2024-09-24 Moldable Bone Graft Matrix

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.