exofin Mastic, 2 oz. EM80212

GUDID 00854137001689

Class 1

CHEMENCE MEDICAL PRODUCTS, INC.

Skin-cover sealant Skin-cover sealant Skin-cover sealant Skin-cover sealant Skin-cover sealant Skin-cover sealant Skin-cover sealant Skin-cover sealant

• Primary Device ID: 00854137001689
• NIH Device Record Key: f45c82fc-e9c4-4afa-94f2-acd6dd9375c0
• Commercial Distribution Discontinuation: 2025-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exofin Mastic, 2 oz.
• Version Model Number: EM80212
• Catalog Number: EM80212
• Company DUNS: 079163089
• Company Name: CHEMENCE MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

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
• 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	00854137001689 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2022-07-05
• Device Publish Date: 2022-06-27

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

• 00854137001665 - LiquidSkin, 1.0g: 2022-07-05
• 00854137001689 - exofin Mastic, 2 oz.: 2022-07-05Class 1
• 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
• 00854137001740 - LiquidSkin, 0.5g: 2022-07-05