Kerecis® Omega3 BURN 50202M21D0D

GUDID 05694310960441

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf

KERECIS hf.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing
Primary Device ID05694310960441
NIH Device Record Keyde2356f1-5803-467b-a7d9-b827342ece37
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerecis® Omega3 BURN
Version Model Number7x20 Meshed Burn
Catalog Number50202M21D0D
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

Device Dimensions

Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 Centimeter
Length7 Centimeter
Width20 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960434 [Primary]
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution
GS105694310960441 [Package]
Contains: 05694310960434
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen
KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [Kerecis® Omega3 BURN]

05694310961127Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310961028Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310961004Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960571Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960557Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960403Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960380Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960366Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310961103Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960670Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960663Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f
05694310960472Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960458Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960441Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960427Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960410Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960045Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo
05694310960021Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo

Trademark Results [Kerecis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
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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