Sure+Close II SC70407

GUDID 00854137001184

Topical Tissue Adhesive

CHEMENCE MEDICAL PRODUCTS, INC.

Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive

• Primary Device ID: 00854137001184
• NIH Device Record Key: 46258cca-cff9-4f30-9a8e-41e50764bf2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure+Close II
• Version Model Number: SC70407
• Catalog Number: SC70407
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com
• Phone: 844-633-6583
• Email: customerservice@chemencemedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854137001184 [Primary]
GS1	10854137001181 [Package]; Package: Box [6 Units]; In Commercial Distribution
GS1	20854137001188 [Package]; Contains: 10854137001181; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101276

FDA Product Code

• MPN: Tissue Adhesive For The Topical Approximation Of Skin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by CHEMENCE MEDICAL PRODUCTS, INC.

• 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
• 00854137001740 - LiquidSkin, 0.5g: 2022-07-05