Kerecis® Shield™ Standard 50215I53B0D
GUDID 05694310964326
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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 | 05694310964326 |
| NIH Device Record Key | 9429b91f-cbe1-409c-99b1-79366bef88d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kerecis® Shield™ Standard |
| Version Model Number | Diameter: 50mm |
| Catalog Number | 50215I53B0D |
| 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 | |
| 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 | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
| Outer Diameter | 50 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
| Storage Environment Temperature | Between 25 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05694310964319 [Primary] |
| GS1 | 05694310964326 [Package] Contains: 05694310964319 Package: Box [10 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 | 2024-01-24 |
| Device Publish Date | 2024-01-16 |
Devices Manufactured by KERECIS hf.
| 05694310964494 - Kerecis® MariGen™ | 2024-09-11 Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full |
| 05694310964517 - Kerecis® MariGen™ | 2024-09-11 |
| 05694310964470 - Kerecis® MariGen™ | 2024-09-10 Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full |
| 05694310964371 - Kerecis® Shield™ Spiral | 2024-06-21 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral is indicated for th |
| 05694310964326 - Kerecis® Shield™ Standard | 2024-01-24Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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/ |
| 05694310964326 - Kerecis® Shield™ Standard | 2024-01-24 Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard is indicated for |
| 05694310963800 - Kerecis® Omega3 SurgiBind | 2022-09-16 Fish skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for implantation to reinforce soft tissue wh |
| 05694310963824 - Kerecis® Omega3 SurgiBind | 2022-09-16 Fsh skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for implantation to reinforce soft tissue whe |
| 05694310963848 - Kerecis® Omega3 SurgiClose | 2022-09-16 Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for the management of wounds including: Partial and f |
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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