Kerecis® Omega3 MariGen 50200N13B0D
GUDID 05694310962247
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 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 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 ID | 05694310962247 |
| NIH Device Record Key | ff84bf8c-c096-48be-9c5f-827b60a43e92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® Omega3 MariGen |
| Version Model Number | Expanse 8x10 cm |
| Catalog Number | 50200N13B0D |
| 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 | false |
| 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 | |
| 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 | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 Centimeter |
| Width | 10 Centimeter |
| Length | 8 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 |
| 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 | 05694310962230 [Primary] |
| GS1 | 05694310962247 [Package] Contains: 05694310962230 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 05694310962261 [Package] Contains: 05694310962230 Package: Box [5 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-25 |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.