AccessGUDID - DEVICE: Performance Tool Organizer Green (00840161300980)

GUDID

Device Identifier (DI) Information

Brand Name: Performance Tool Organizer Green
Version or Model: 50Z940D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161300980
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use
Previous DI: D68550Z940D0

Device Description: "Ideal for Large Specialty Instruments Customizable, removable feet Superior water flow for superb cleaning Compact styling to fit most sterilizers Attached cover that rolls back easily Dimensions: 8-3/16” x 4-1/4” x 1-7/32” Autoclavable up to 136°C/277F°"

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
FSM	Tray, Surgical, Instrument

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
Length: 211 Millimeter
Width: 108 Millimeter
Height: 32 Millimeter

Device Record Status

Public Device Record Key: ac647fa7-c92e-4963-bcab-a6b58629edf8
Public Version Date: November 02, 2022
Public Version Number: 1
DI Record Publish Date: October 25, 2022