Kerecis® Omega3 MariGen 50200S01B0D

GUDID 05694310962391

Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen

KERECIS hf.

Collagen wound matrix dressing
Primary Device ID05694310962391
NIH Device Record Keye1cfcd0a-08d4-4adb-90b3-526c6efe63f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerecis® Omega3 MariGen
Version Model Number3x3.5 cm
Catalog Number50200S01B0D
Company DUNS365732410
Company NameKERECIS hf.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com
Phone7032878752
Emailinfo@kerecis.com

Device Dimensions

Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter
Length3 Centimeter
Width3.5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS105694310962391 [Primary]
GS105694310962407 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-05-11
Device Publish Date2022-02-17

On-Brand Devices [Kerecis® Omega3 MariGen]

05694310962247Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310962223Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310961608Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310960908Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310690133Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310690157Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310690096Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310961660Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310961622Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310961578Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310962445Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310962414Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of
05694310962391Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of

Trademark Results [Kerecis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KERECIS
KERECIS
98485911 not registered Live/Pending
Kerecis Limited
2024-04-05
KERECIS
KERECIS
87943872 not registered Live/Pending
Kerecis Limited
2018-05-31
KERECIS
KERECIS
87489452 not registered Dead/Abandoned
Kerecis EHF
2017-06-14

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