PLENA MEDIUM PDM2030

GUDID 00813954027104

Regenerative Collagen Dental Membrane

COLLAGEN MATRIX, INC.

Collagen dental regeneration membrane
Primary Device ID00813954027104
NIH Device Record Key1da5e305-81a4-45ea-a5b3-d37da5b16de3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLENA MEDIUM
Version Model NumberPDM2030
Catalog NumberPDM2030
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954027104 [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 MEDIUM]

00813954024646Regenerative Collagen Dental Membrane 30mm x 40mm
00813954024639Regenerative Collagen Dental Membrane 20mm x 30mm
00813954024622Regenerative Collagen Dental Membrane 15mm x 20mm
00813954027104Regenerative Collagen Dental Membrane
00813954027098Regenerative Collagen Dental Membrane

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