Kerecis® Omega3 BURN 50202N24D0D

GUDID 05694310961004

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). Mesh ratio 2:1 Pentagon 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
Primary Device ID05694310961004
NIH Device Record Key3985565d-8cf0-4026-a6a9-a46f9a68ad38
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerecis® Omega3 BURN
Version Model Number250cm2 Meshed Burn
Catalog Number50202N24D0D
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

Device Dimensions

Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 Centimeter
Length250 Centimeter
Width250 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310960991 [Primary]
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
Package: Box [10 Units]
In Commercial Distribution
GS105694310961004 [Package]
Contains: 05694310960991
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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

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

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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