PLENA FLEX CDMPP2030

GUDID 00813954027043

Resorbable Collagen Membrane for Dental Surgery

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00813954027043
NIH Device Record Key78d35595-af27-4043-886b-efcd41c3061f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLENA FLEX
Version Model NumberCDMPP2030
Catalog NumberCDMPP2030
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

Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com
Phone844-862-7846
Emailinfo@sweden-martina.com

Device Dimensions

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Device Size Text, specify0
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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
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
GS100813954027043 [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 Date2025-07-23
Device Publish Date2025-07-15

On-Brand Devices [PLENA FLEX]

00813954024615Resorbable Collagen Membrane For Dental Surgery 30mm x 40mm
00813954024608Resorbable Collagen Membrane For Dental Surgery 20mm x 30mm
00813954024592Resorbable Collagen Membrane For Dental Surgery 15mm x 20mm
00813954027043Resorbable Collagen Membrane for Dental Surgery
00813954027036Resorbable Collagen Membrane for Dental Surgery

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