Torque Calibrator

GUDID 04560264522336

NAKANISHI INC.

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Primary Device ID04560264522336
NIH Device Record Key7febf1a2-6f47-4a7d-9096-391df459e017
Commercial Distribution StatusIn Commercial Distribution
Brand NameTorque Calibrator
Version Model NumberTorque Calibrator
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 Datefalse
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
GS104560264522336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-11-30
Device Publish Date2020-11-20

Devices Manufactured by NAKANISHI INC.

04560264500730 - Primado22024-04-03
04560264500747 - Primado22024-04-03
04560264511668 - Primado22024-04-03
04560264511675 - Primado22024-04-03
04560264511705 - Primado22024-04-03
04560264511736 - Primado22024-04-03
04560264523081 - Primado22024-04-03
04560264523098 - Primado22024-04-03

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