FC-81

GUDID 04589551389414

NAKANISHI INC.

Foot-switch, electrical
Primary Device ID04589551389414
NIH Device Record Key878f9a46-5d7a-46ed-8c98-2247220dde39
Commercial Distribution StatusIn Commercial Distribution
Brand NameFC-81
Version Model NumberFC-81
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104589551389414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

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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