SGL70M

GUDID 04560264557529

NAKANISHI INC.

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Primary Device ID04560264557529
NIH Device Record Key34f7a709-6fee-4639-ba9a-5babe2ca7f12
Commercial Distribution StatusIn Commercial Distribution
Brand NameSGL70M
Version Model NumberSGL70M
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
GS104560264557529 [Direct Marking]
GS104560264557581 [Primary]

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


[04560264557529]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-10-22
Device Publish Date2018-08-16

On-Brand Devices [SGL70M]

04560264557529SGL70M
04560264527454SGL70M

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