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 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: 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
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: info@kerecis.com
• Phone: 7032878752
• Email: 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

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

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.

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• 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
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• 05694310963923 - 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