Kerecis® OR 50205S23D0D

GUDID 05694310960786

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indicated for the management of wounds including: - Partial and full-thickness wounds, - Pressure ulcers, - Chronic vascular ulcers, - Diabetic ulcers, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears), - Surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence - Draining wounds. Trapezoid https://www.kerecis.com/wp-content/uploads/2020/10/KM-20-0079-IFU-Kerecis-Omega3-OR-US.pdf Double Pouched

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 ID05694310960786
NIH Device Record Key89545b53-4f31-42ff-bd82-0ac631522a32
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerecis® OR
Version Model Number300cm2 Solid OR
Catalog Number50205S23D0D
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

Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 Centimeter
Length300 Centimeter
Width300 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
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]
GS105694310960786 [Primary]

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® OR]

05694310961066Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica
05694310961042Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica
05694310960786Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica
05694310960762Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica
05694310960724Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica
05694310960717Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega3 OR is indica

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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