AccessGUDID - DEVICE: Sugita Titanium Clip II Metal Case (04946329376296)

GUDID

Device Identifier (DI) Information

Brand Name: Sugita Titanium Clip II Metal Case
Version or Model: 17-010-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-010-20
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329376296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: Sugita Titanium Clip II Metal Case A for Appliers

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?
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	Obsolete	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: 514 Millimeter

Device Record Status

Public Device Record Key: 47837a54-cb80-4659-bf32-de8a73aef0ca
Public Version Date: February 11, 2022
Public Version Number: 1
DI Record Publish Date: February 03, 2022