Suture Strip® DERMA-TS3104B

GUDID 00809958000199

Suture strip Wound Closure Strips

Derma Sciences Canada Inc

Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip Skin-closure adhesive strip

• Primary Device ID: 00809958000199
• NIH Device Record Key: 75bb3ada-c4d6-495f-999c-d06582686219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suture Strip®
• Version Model Number: TS-3104B
• Catalog Number: DERMA-TS3104B
• Company DUNS: 200564891
• Company Name: Derma Sciences Canada Inc
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00809958000175 [Primary]
GS1	00809958000182 [Unit of Use]
GS1	00809958000199 [Package]; Contains: 00809958000175; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894205

FDA Product Code

• FPX: Strip, adhesive, closure, skin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-23
• Device Publish Date: 2018-10-23

On-Brand Devices [Suture Strip®]

• 00809958000199: Suture strip Wound Closure Strips
• 00809958000168: Suture strip Wound Closure Strips
• 00809958000137: Suture strip Wound Closure Strips
• 00809958000106: Suture strip Wound Closure Strips
• 30753567331049: Suture strip Wound Closure Strips
• 30753567331032: Suture strip Wound Closure Strips
• 30753567331025: Suture strip Wound Closure Strips