AccessGUDID - DEVICE: HYGITECH (03615140000062)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-90030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-90030
Company Name: HYGITECH

Primary DI Number: 03615140000062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: Tray Dimensions: 60 x 40 cm • Height between shelves for the 2 shelves model: 52 cm • Height between shelves for the 3 shelves model: 31 cm

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?
34909	Instrument trolley	A cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport).	Obsolete	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: e31959f1-370c-4c63-a8b7-7440a6778543
Public Version Date: December 22, 2020
Public Version Number: 1
DI Record Publish Date: December 14, 2020