OverStitch NXT Endoscopic Suturing System ESS-G02-NXT

GUDID 00811955020896

Needle Driver and Anchor Exchange

Apollo Endosurgery, Inc.

Suturing unit, single-use

• Primary Device ID: 00811955020896
• NIH Device Record Key: a728d802-6bb4-4dbe-8f3b-e6f425423719
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OverStitch NXT Endoscopic Suturing System
• Version Model Number: ESS-G02-NXT
• Catalog Number: ESS-G02-NXT
• 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	00811955020896 [Primary]
GS1	10811955020893 [Package]; Package: Sales Carton [3 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

On-Brand Devices [OverStitch NXT Endoscopic Suturing System]

• 00811955020896: Needle Driver and Anchor Exchange
• 00811955020834: Needle Driver and Anchor Exchange