AccessGUDID - DEVICE: ETHICON Linx Esophagus Sizing Tool (10855106005438)

GUDID

Device Identifier (DI) Information

Brand Name: ETHICON Linx Esophagus Sizing Tool
Version or Model: LST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LST
Company Name: Torax Medical, Inc.

Primary DI Number: 10855106005438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137949538 *Terms of Use

Device Description: ETHICON Linx Esophagus Sizing Tool

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
35695	Gastro-oesophageal antireflux prosthesis	An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QJN	Laparoscopic accessories, esophageal sizing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201035	000

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: 408ba3f4-d3da-41a1-9f63-78a75d0d6aff
Public Version Date: December 31, 2020
Public Version Number: 1
DI Record Publish Date: December 23, 2020