Kerecis® Omega3 MariGen 50200S03B0D
GUDID 05694310962445
Fish-skin graft for wound management. Kerecis Omega3 MariGen 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) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen/
KERECIS hf.
Collagen wound matrix dressing| Primary Device ID | 05694310962445 |
| NIH Device Record Key | 76132f90-8243-4433-809c-186f6f6b70ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® Omega3 MariGen |
| Version Model Number | 7x10 cm |
| Catalog Number | 50200S03B0D |
| 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 | false |
| 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 | |
| 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 |
| 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
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling 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 | 05694310962438 [Primary] |
| GS1 | 05694310962445 [Package] Contains: 05694310962438 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132343
FDA Product Code
| KGN | Dressing, Wound, Collagen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-05-11 |
| Device Publish Date | 2022-02-17 |
On-Brand Devices [Kerecis® Omega3 MariGen]
| 05694310962247 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310962223 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310961608 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310960908 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310690133 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310690157 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310690096 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310961660 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310961622 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310961578 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310962445 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310962414 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
| 05694310962391 | Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of |
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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