Kerecis® MariGen® 50200O46B0D
GUDID 05694310965354
Fish-skin graft for wound management. Kerecis® MariGen® is indicated for the management of wounds including: Partial-thickness wounds (extending through the epidermis or into dermis), Full-thickness wounds (extending through the dermis to deeper tissues such as subcutaneous fat, muscle, tendon or bone), 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-marigen/
KERECIS hf.
Animal-derived wound matrix dressing| Primary Device ID | 05694310965354 |
| NIH Device Record Key | ea5bcbb0-67a8-45fd-9ed0-1aae2456b3c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® MariGen® |
| Version Model Number | Expanse cm 6 x 6 / Meshed 3:1 |
| Catalog Number | 50200O46B0D |
| 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 |
Device Dimensions
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 Centimeter |
| Length | 6 Centimeter |
| Width | 6 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05694310965347 [Primary] |
| GS1 | 05694310965354 [Package] Contains: 05694310965347 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132343
FDA Product Code
| KGN | Wound Dressing With Animal-Derived Material(S) |
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 | 2025-09-08 |
| Device Publish Date | 2025-08-29 |
Devices Manufactured by KERECIS hf.
| 05694310965354 - Kerecis® MariGen® | 2025-09-08Fish-skin graft for wound management. Kerecis® MariGen® is indicated for the management of wounds including: Partial-thickness wounds (extending through the epidermis or into dermis), Full-thickness wounds (extending through the dermis to deeper tissues such as subcutaneous fat, muscle, tendon or bone), 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-marigen/ |
| 05694310965354 - Kerecis® MariGen® | 2025-09-08 Fish-skin graft for wound management. Kerecis® MariGen® is indicated for the management of wounds including: Partial-thickness |
| 05694310965378 - Kerecis® GraftGuide® | 2025-09-08 Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial a |
| 05694310965392 - Kerecis® SurgiClose® Silicone | 2025-08-28 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the ma |
| 05694310965415 - Kerecis® SurgiClose® Silicone | 2025-08-28 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the ma |
| 05694310965439 - Kerecis® SurgiClose® Silicone | 2025-08-28 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the ma |
| 05694310965453 - Kerecis® SurgiClose® Silicone | 2025-08-28 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the ma |
| 05694310963954 - Kerecis® GraftGuide™ Mano | 2025-07-21 Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Par |
| 05694310963985 - Kerecis® GraftGuide™ Mano | 2025-07-21 Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Par |
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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