Collatene DWDG0010

GUDID 10813954022052

Microfibrillar Collagen Dental Wound Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived
Primary Device ID10813954022052
NIH Device Record Keyc6fd98d0-8e43-4ee2-be6b-649ebffd1dd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollatene
Version Model NumberDWDG0010
Catalog NumberDWDG0010
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

Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com
Phone12014051477
EmailCMIcontact@collagenmatrix.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store dry at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954022055 [Primary]
GS110813954022052 [Package]
Contains: 00813954022055
Package: box [15 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 Date2023-02-10
Device Publish Date2023-02-02

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