TenSURE FG-0017-02

GUDID 30840143903728

TenSURE Suture Tightener

ATRICURE, INC.

Suture knot-tying device

• Primary Device ID: 30840143903728
• NIH Device Record Key: 40dc9f5d-1416-4ada-ae6a-2d490f128655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TenSURE
• Version Model Number: 80-02
• Catalog Number: FG-0017-02
• Company DUNS: 006133784
• Company Name: ATRICURE, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840143901911 [Previous]
GS1	10840143904455 [Primary]
GS1	30840143903728 [Package]; Contains: 10840143904455; Package: Box [1 Units]; In Commercial Distribution
GS1	50840143903258 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FZT: Cutter, Surgical

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: 2021-08-06
• Device Publish Date: 2021-07-29

On-Brand Devices [TenSURE]

• 00818354017618: A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature lo
• 30840143901915: TenSURE Suture Tightener
• 30840143903728: TenSURE Suture Tightener
• 30840143909683: TenSURE Suture Tightener