DEVICE: OSADA ENDEX PLUS (04580406860416)

Device Identifier (DI) Information

OSADA ENDEX PLUS
EM-S8
In Commercial Distribution
5035
OSADA ELECTRIC CO.,LTD.
04580406860416
GS1

1
690713813 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LQY Locator, root apex
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904742 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

fdb3c41e-911b-446e-9557-3678d23cc12a
July 06, 2018
3
September 20, 2016
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE