Kerecis® Omega3 Wound 50200S12B0D

GUDID 05694310960120

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound 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) •Draining Wounds 12 mm Circular https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.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 ID05694310960120
NIH Device Record Keyfc7696bc-9af3-44f8-9d6f-e9a9a298aae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerecis® Omega3 Wound
Version Model Number12 mm Solid Circular Wound
Catalog Number50200S12B0D
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

Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter
Circumference12 Millimeter

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
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960113 [Primary]
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
Package: Box [10 Units]
In Commercial Distribution
GS105694310960120 [Package]
Contains: 05694310960113
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 Wound]

05694310960267Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960236Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960328Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960311Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960304Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960281Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960229Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960205Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960182Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960151Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960144Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960120Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind
05694310960069Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is ind

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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.