AccessGUDID - DEVICE: Root ZX II Canal Measurement Module (04548213013227)

GUDID

Device Identifier (DI) Information

Brand Name: Root ZX II Canal Measurement Module
Version or Model: DP-ZX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: J.MORITA MFG.CORP.

Primary DI Number: 04548213013227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 693811465 *Terms of Use

Device Description: No description.

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?
31876	Endodontic enlarger, reusable	A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQY	Locator, Root Apex

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071190	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Storage Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa11ced2-0cfc-4748-9199-bbb112ae5d0e
Public Version Date: September 24, 2018
Public Version Number: 4
DI Record Publish Date: August 31, 2016