Exofin

GUDID 00897392002244

Topic Skin Adhesive - ExofinMicro .5ml

Sourcemark, Llc.

Skin-approximation adhesive

• Primary Device ID: 00897392002244
• NIH Device Record Key: 49ad70ff-74c4-4bd6-8831-3fcc702aa324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exofin
• Version Model Number: M1206
• Company DUNS: 121225812
• Company Name: Sourcemark, Llc.
• 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: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com
• Phone: 615-269-6010
• Email: customerservice@sourceMarkusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897392002244 [Primary]
GS1	10897392002975 [Package]; Package: Box [6 Units]; In Commercial Distribution
GS1	20897392004402 [Package]; Contains: 10897392002975; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132243

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: 5
• Public Version Date: 2019-09-27
• Device Publish Date: 2016-10-27

On-Brand Devices [Exofin]

• 00897392002244: Topic Skin Adhesive - ExofinMicro .5ml
• 00897392002237: Topic Skin Adhesive - Exofin 1.0ml