Kerecis® Omega3 BURN 50202M13B0D
GUDID 05694310960021
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| Primary Device ID | 05694310960021 |
| NIH Device Record Key | 4b15a4b4-8161-4ce6-8262-327fa1270762 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® Omega3 BURN |
| Version Model Number | 7x10 Meshed Burn |
| Catalog Number | 50202M13B0D |
| Company DUNS | 365732410 |
| Company Name | KERECIS hf. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com | |
| Phone | 7032878752 |
| info@kerecis.com |
Device Dimensions
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
| Length | 7 Centimeter |
| Width | 10 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05694310960014 [Primary] |
| GS1 | 05694310960021 [Package] Contains: 05694310960014 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| KGN | Dressing, Wound, Collagen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-23 |
| Device Publish Date | 2021-02-15 |
On-Brand Devices [Kerecis® Omega3 BURN]
| 05694310961127 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310961028 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310961004 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960571 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960557 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960403 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960380 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960366 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310961103 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960670 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960663 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated f |
| 05694310960472 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960458 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960441 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960427 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960410 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960045 | Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated fo |
| 05694310960021 | Acellular 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 98485911 not registered Live/Pending |
Kerecis Limited 2024-04-05 |
 KERECIS 87943872 not registered Live/Pending |
Kerecis Limited 2018-05-31 |
 KERECIS 87489452 not registered Dead/Abandoned |
Kerecis EHF 2017-06-14 |
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