AccessGUDID - DEVICE: Sugita T2 Clip Tray (04946329221107)

GUDID

Device Identifier (DI) Information

Brand Name: Sugita T2 Clip Tray
Version or Model: 17-010-97
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-010-97
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329221107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: Sugita T2 Clip Tray H. (Customizable Tray for Standard and Mini Clips with 25 Blank Pockets)

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):	Yes
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?
32581	Surgical clip rack	A device typically designed as a container used to hold and protect implantable clips during the sterilization process. The rack also serves to hold the clips in the proper geometric orientation to permit mating with the clip applier used during the clip's application. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBR	Rack, Clip

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 9.36 Inch

Device Record Status

Public Device Record Key: 94e47fc9-816c-4c31-b6e6-f39c584f26a9
Public Version Date: April 13, 2022
Public Version Number: 1
DI Record Publish Date: April 05, 2022