endomina EZFuse suture

GUDID 05425029282643

endomina EZFuse suture

Endo Tools Therapeutics

Suturing unit, single-use

• Primary Device ID: 05425029282643
• NIH Device Record Key: b67e1aa1-d53c-4b53-a272-8b36871204fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: endomina EZFuse suture
• Version Model Number: endomina EZFuse suture
• Company DUNS: 400000750
• Company Name: Endo Tools Therapeutics
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425029282049 [Primary]
GS1	05425029282131 [Package]; Contains: 05425029282346; Package: Pallet [8 Units]; In Commercial Distribution
GS1	05425029282346 [Package]; Contains: 05425029282049; Package: Tertiary packaging [12 Units]; In Commercial Distribution
GS1	05425029282384 [Package]; Contains: 05425029282346; Package: Pallet [20 Units]; In Commercial Distribution
GS1	05425029282452 [Package]; Contains: 05425029282346; Package: Pallet [12 Units]; In Commercial Distribution
GS1	05425029282643 [Package]; Contains: 05425029282049; Package: secondary packaging [6 Units]; In Commercial Distribution
GS1	05425029282766 [Package]; Contains: 05425029282346; Package: Pallet [16 Units]; In Commercial Distribution
GS1	05425029282889 [Package]; Contains: 05425029282346; Package: Pallet [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252400

FDA Product Code

• OCW: Endoscopic Tissue Approximation Device

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: 2026-03-27
• Device Publish Date: 2026-03-19

Devices Manufactured by Endo Tools Therapeutics

• 05425029282643 - endomina EZFuse suture: 2026-03-27endomina EZFuse suture
• 05425029282643 - endomina EZFuse suture: 2026-03-27 endomina EZFuse suture
• 05425029282599 - endomina EZFuse system: 2026-03-27 endomina EZFuse system composed of 1 endomina platform and 6 endomina EZFuse suture
• 05425029282117 - endomina platform: 2022-07-27 endomina platform primary packaging (x1)
• 05425029282070 - endomina system: 2022-07-27 endomina system is composed of 1 endomina platform and 6 TAPES
• 05425029282698 - TAPES: 2022-07-27 TAPES primary packaging (x1)