AccessGUDID - DEVICE: NA (05060247261973)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Sonic Irrigator PCF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MED11132
Company Name: MEDISAFE UK LIMITED

Primary DI Number: 05060247261973
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 505942961 *Terms of Use

Device Description: The Sonic Irrigator PCF Washer Disinfector uses a combination of ultrasonic technology and controlled irrigation.

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?
66797	Surgical instrument washer/disinfector (chemical/thermal)	An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, medical devices

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: b58c564a-c49e-4a99-875a-2cf6ae40f40f
Public Version Date: November 21, 2023
Public Version Number: 7
DI Record Publish Date: September 16, 2016