NXT Tissue Helix Pro NXT-THXP-130

GUDID 10811955020916

Tissue Helix

Apollo Endosurgery, Inc.

Suturing unit, single-use

• Primary Device ID: 10811955020916
• NIH Device Record Key: 693c2d26-fa47-4f6d-9ebc-71f77bcc04ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT Tissue Helix Pro
• Version Model Number: NXT-THXP-130
• Catalog Number: NXT-THXP-130
• Company DUNS: 625064352
• Company Name: Apollo Endosurgery, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplaints.us@apolloendo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811955020919 [Primary]
GS1	10811955020916 [Package]; Contains: 00811955020919; Package: Shelf Carton [6 Units]; In Commercial Distribution

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: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by Apollo Endosurgery, Inc.

• 00811955020834 - OverStitch NXT Endoscopic Suturing System: 2024-10-09 Needle Driver and Anchor Exchange
• 00811955020896 - OverStitch NXT Endoscopic Suturing System: 2023-11-24 Needle Driver and Anchor Exchange
• 10811955020916 - NXT Tissue Helix Pro: 2023-11-24Tissue Helix
• 10811955020916 - NXT Tissue Helix Pro: 2023-11-24 Tissue Helix
• 00811955020933 - Apollo ESG NXT System: 2023-11-24 Single Channel Endobariatric System
• 00811955020940 - Apollo Revise NXT System: 2023-11-24 Single Channel Endobariatric System
• 00811955020780 - APOLLO ESG™ System: 2023-05-15 Dual Channel Endobariatric System
• 00811955020797 - APOLLO ESG Sx™ System: 2023-05-15 Single Channel Endobariatric System
• 00811955020803 - APOLLO Revise™ System: 2023-05-15 Dual Channel Endobariatric System