AccessGUDID - DEVICE: HYDRIM C51W Instrument Washer (07540196000048)

GUDID

Device Identifier (DI) Information

Brand Name: HYDRIM C51W Instrument Washer
Version or Model: C51W-D01-R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C51W-D01-R
Company Name: Scican Ltd

Primary DI Number: 07540196000048
Issuing Agency: GS1
Commercial Distribution End Date: June 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 204137145 *Terms of Use

Device Description: Automated instrument washer (Refurbished)

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):	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?
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
LDS	Device, Pasteurization, Hot Water

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: 3a4c5660-47b4-4679-9072-c6f5cc341429
Public Version Date: June 14, 2023
Public Version Number: 3
DI Record Publish Date: August 02, 2016