PD-CU-551

GUDID 04589551362967

NAKANISHI INC.

Multi-purpose surgical power tool system, line-powered
Primary Device ID04589551362967
NIH Device Record Key1d182bab-f1fa-4c74-8832-3bdfcc9d8d99
Commercial Distribution StatusIn Commercial Distribution
Brand NamePD-CU-551
Version Model NumberPD-CU-551
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 Batchtrue
Serial Numberfalse
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
GS104589551362967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBCMOTOR, DRILL, ELECTRIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-03
Device Publish Date2022-02-23

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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