Kerecis® GraftGuide® 50202O23D0D

GUDID 05694310965378

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/

KERECIS hf.

Animal-derived wound matrix dressing

• Primary Device ID: 05694310965378
• NIH Device Record Key: d66344a6-fb3a-4441-b293-a84b9c78577b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kerecis® GraftGuide®
• Version Model Number: 300 sq cm Meshed 3:1
• Catalog Number: 50202O23D0D
• 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

Device Dimensions

• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square centimeter
• Area/Surface Area: 300 Square 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05694310965361 [Primary]
GS1	05694310965378 [Package]; Contains: 05694310965361; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190528

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.

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• 05694310965378 - Kerecis® GraftGuide®: 2025-09-08Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
• 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