Exofin Fusion Skin Closure System, 6cm

GUDID 00854137001610

CHEMENCE MEDICAL PRODUCTS, INC.

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

• Primary Device ID: 00854137001610
• NIH Device Record Key: 6acdbe61-1b26-4082-8294-d2a6c82ed099
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exofin Fusion Skin Closure System, 6cm
• Version Model Number: EF70406
• 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

Customer Support Contacts

• Phone: 18446334583
• Email: customerservice@chemence.com
• Phone: 18446334583
• Email: customerservice@chemence.com
• Phone: 18446334583
• Email: customerservice@chemence.com
• Phone: 18446334583
• Email: customerservice@chemence.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854137001603 [Primary]
GS1	00854137001610 [Package]; Contains: 00854137001603; Package: Inner Sleeve [6 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: 2022-05-23
• Device Publish Date: 2022-05-13

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