OverStitch NXT Endoscopic Suturing System

Basic Information

• Brand Name: OverStitch NXT Endoscopic Suturing System
• Primary DI: 00811955020896
• Version / Model: ESS-G02-NXT
• Catalog Number: ESS-G02-NXT
• Company Name: Apollo Endosurgery, Inc.
• Labeler DUNS: 625064352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-16
• Public Version: 1
• Public Version Date: 2023-11-24
• Public Version Status: New
• Public Device Record Key: a728d802-6bb4-4dbe-8f3b-e6f425423719

Device Description

Needle Driver and Anchor Exchange

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57874	Suturing unit, single-use	A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811955020896	GS1
Package	10811955020893	GS1	Sales Carton	3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]