Kerecis® Shield® Adhesive 50215H50B0D
GUDID 05694310965194
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive 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, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Collagen wound matrix dressing| Primary Device ID | 05694310965194 |
| NIH Device Record Key | 368db16c-f515-47c4-9210-8a7d66da3a5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® Shield® Adhesive |
| Version Model Number | 15mm Circular |
| Catalog Number | 50215H50B0D |
| 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 | |
| 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
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
| Outer Diameter | 15 Millimeter |
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 |
| 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 | 05694310965187 [Primary] |
| GS1 | 05694310965194 [Package] Contains: 05694310965187 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 05694310965200 [Package] Contains: 05694310965187 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213231
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 | 2024-12-30 |
| Device Publish Date | 2024-12-20 |
Devices Manufactured by KERECIS hf.
| 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 |
| 05694310964005 - 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 |
| 05694310964029 - 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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