PLENA WOUND DRESSING FOAM BDDWDF2040

GUDID 10813954027163

Collagen Dental Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived
Primary Device ID10813954027163
NIH Device Record Key8e2885de-9472-43cb-b785-87b5524331ae
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLENA WOUND DRESSING FOAM
Version Model NumberBDDWDF2040
Catalog NumberBDDWDF2040
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

Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.com
Phone1-844-862-7846
Emailinfo@sweden-martina.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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954027166 [Primary]
GS110813954027163 [Package]
Contains: 00813954027166
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-24
Device Publish Date2025-07-16

Devices Manufactured by COLLAGEN MATRIX, INC.

00813954027272 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027289 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027296 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027302 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027319 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027326 - Arthrex Nerve Conduit2025-08-04 Flexible Collagen Nerve Tube
00813954027333 - Arthrex Nerve Wrap2025-08-04 Collagen Nerve Protector
00813954027340 - Arthrex Nerve Wrap2025-08-04 Collagen Nerve Protector

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