FC-15

GUDID 04589551386765

NAKANISHI INC.

Foot-switch, electrical
Primary Device ID04589551386765
NIH Device Record Keyec24f2a0-88cd-46c4-bead-03b83be75ff1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFC-15
Version Model NumberFC-15
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589551386765 [Primary]

FDA Product Code

EKXHandpiece, direct drive, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-13
Device Publish Date2023-06-05

Devices Manufactured by NAKANISHI INC.

04589551383993 - Bur Stopper2024-11-21
04589551384006 - Bur Stopper Puller2024-11-21
04560264502963 - PTL Nozzle2024-11-11
04560264502970 - EZ-M4 Adaptor2024-11-11
04589551392063 - EZ SPRAY2024-11-11
04589551391950 - M2052024-10-24
04560264578586 - FX204 M42024-10-24
04589551389391 - Surgic Pro2 OPT2024-10-23

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