Surgical Straight Handpiece

GUDID 04560264556270

NAKANISHI INC.

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Primary Device ID04560264556270
NIH Device Record Keya935225d-32c0-4c11-a432-4c564cf12e2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical Straight Handpiece
Version Model NumberSGS-ES
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
GS104560264556270 [Primary]
GS104560264557338 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


[04560264556270]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2018-01-22

On-Brand Devices [Surgical Straight Handpiece]

04560264556294SGS-E2S
04560264556270SGS-ES

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