AccessGUDID - DEVICE: Versajet (00040565125497)

GUDID

Device Identifier (DI) Information

Brand Name: Versajet
Version or Model: 66800474
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66800474
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 00040565125497
Issuing Agency: GS1
Commercial Distribution End Date: February 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Versajet II Console User Guide

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:	No
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?
36961	Water jet knife system generator	A mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	Lavage, Jet

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143115	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 6d0b656b-4a68-4477-86ed-69998f23bbbc
Public Version Date: February 20, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 2016