P300-2A80

GUDID 04589551355228

NAKANISHI INC.

Burring power tool attachment
Primary Device ID04589551355228
NIH Device Record Key4b33e8cf-651c-4f76-a5f1-439e2a5a1860
Commercial Distribution StatusIn Commercial Distribution
Brand NameP300-2A80
Version Model NumberP300-2A80
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
GS104589551355167 [Primary]
GS104589551355228 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


[04589551355228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-11-21
Device Publish Date2022-09-15

Devices Manufactured by NAKANISHI INC.

04560264575158 - Nozzle Holder2024-11-25
04560264575165 - Nozzle Holder2024-11-25
04560264575172 - Internal Spray Nozzle2024-11-25
04560264575189 - Cleaning Wire2024-11-25
04560264575271 - Tube Holder2024-11-25
04560264576506 - Protection Plug2024-11-25
04560264576513 - Coolant Solution Hanger Post2024-11-25
04589551392421 - Tube Holder2024-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.