AccessGUDID - DEVICE: EndoSync A.I. (00887919758013)

GUDID

Device Identifier (DI) Information

Brand Name: EndoSync A.I.
Version or Model: RCM-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5025412U0
Company Name: J.MORITA MFG.CORP.

Primary DI Number: 00887919758013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 693811465 *Terms of Use

Device Description: Apex Locator

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:	Yes
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?
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. 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 [?]
K090925	000

Device Exempt from Premarket Submission: No 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
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 45 Degrees Celsius
Storage Environment Humidity: between 8 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0984d19d-a9cb-4be2-a1e5-07b62df11dc3
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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