AccessGUDID - DEVICE: HYGITECH (03615140000086)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-90070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-90070
Company Name: HYGITECH

Primary DI Number: 03615140000086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: The infusion stand is ideal for irrigation during implant surgery. Manual height adjustment: max 2 meters More info Total diameter: 30 mm Wheelbase: 52 cm Maximum load per hook: 6kg 2 year warranty Made in France

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:	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?
10298	Bowl/basin stand	A device that typically consists of a framework designed to support a bowl or basin in a recess at the top of the device. The stand may be stationary or mobile and is typically used in operating theatres, examination rooms, accident and emergency (A&E) rooms, or bedside.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFJ	Mallet, Surgical, General & Plastic Surgery

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: c74ba0ce-2b15-4df5-9e3c-f52374b2931f
Public Version Date: December 22, 2020
Public Version Number: 1
DI Record Publish Date: December 14, 2020