AccessGUDID - DEVICE: OverStitch NXT Endoscopic Suturing System (00811955020896)

GUDID

Device Identifier (DI) Information

Brand Name: OverStitch NXT Endoscopic Suturing System
Version or Model: ESS-G02-NXT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ESS-G02-NXT
Company Name: Apollo Endosurgery, Inc.

Primary DI Number: 00811955020896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625064352 *Terms of Use

Device Description: Needle Driver and Anchor Exchange

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCW	Endoscopic Tissue Approximation Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a728d802-6bb4-4dbe-8f3b-e6f425423719
Public Version Date: November 24, 2023
Public Version Number: 1
DI Record Publish Date: November 16, 2023