exofin Fusion Skin Closure System, 60cm EF70466

GUDID 00854137001511

CHEMENCE MEDICAL PRODUCTS, INC.

Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical Wound closure set, topical

• Primary Device ID: 00854137001511
• NIH Device Record Key: 637cac80-ab0b-4f03-b9c0-9bf997a90b54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exofin Fusion Skin Closure System, 60cm
• Version Model Number: EF70466
• Catalog Number: EF70466
• Company DUNS: 079163089
• Company Name: CHEMENCE MEDICAL PRODUCTS, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854137001504 [Primary]
GS1	00854137001511 [Package]; Contains: 00854137001504; Package: Inner Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171442

FDA Product Code

• OMD: Cutaneous Tissue Adhesive With Mesh

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: 2022-02-22
• Device Publish Date: 2022-02-14

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

• 00854137001979 - exofin SC: 2024-06-28 exofin® SC High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacryl
• 00854137001665 - LiquidSkin, 1.0g: 2022-07-05
• 00854137001689 - exofin Mastic, 2 oz.: 2022-07-05 Class 1
• 00854137001696 - exofin Mastic, 0.67ml: 2022-07-05 Class 1
• 00854137001702 - exofin Mastic, 1 oz.: 2022-07-05 Class 1
• 00854137001719 - GluGone Adhesive Remover, 2 oz.: 2022-07-05 Glugone 2 oz
• 00854137001726 - GluGone Adhesive Remover, 4 oz.: 2022-07-05 4 OZ
• 10854137001730 - GluGone Adhesive Remover, 0.67 oz.: 2022-07-05 0.67 OZ