AccessGUDID - DEVICE: Tenex Health TX (20857156006073)

GUDID

Device Identifier (DI) Information

Brand Name: Tenex Health TX
Version or Model: 554-4003-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 554-4003-002
Company Name: TENEX HEALTH, INC.

Primary DI Number: 20857156006073
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 038720788 *Terms of Use

Device Description: TX-DFU Procedure Pack, Shelf Pack

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":	Yes
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?
37776	Ultrasonic suction system	An assembly of mains electricity (AC-powered) devices designed to use mechanical ultrasonic vibration and a combination of irrigation and suction to fragment and remove soft tissue and growths of high water content from various parts of the body. Ultrasonic suction units are used during neurosurgery, general surgery, and gynaecological and orthopaedic procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181367	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: d7a176fb-c88d-4f1f-94f6-b11c0fa0d615
Public Version Date: January 07, 2025
Public Version Number: 2
DI Record Publish Date: February 23, 2022