AccessGUDID - DEVICE: InnoWave (00724995152734)

GUDID

Device Identifier (DI) Information

Brand Name: InnoWave
Version or Model: IWULTRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IWULTRA
Company Name: MEDISAFE UK LIMITED

Primary DI Number: 00724995152734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 505942961 *Terms of Use

Device Description: The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a variety of reusable surgical instruments.

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):	No
Over the Counter (OTC):	Yes
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?
36749	Ultrasonic-cleaning water bath	An electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, ultrasonic, medical instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 5304ba2a-450f-4086-a3e7-c72bf2ef3232
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: March 31, 2021