Ti-Max X

GUDID 04560264528499

NAKANISHI INC.

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Primary Device ID04560264528499
NIH Device Record Keyc4089647-7b43-45b5-8b7c-177d302fb728
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi-Max X
Version Model NumberX-DSG20Lh
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
GS104560264528499 [Primary]
GS104560264557178 [Direct Marking]

FDA Product Code

KMWHANDPIECE, ROTARY BONE CUTTING

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


[04560264528499]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-09-16

On-Brand Devices [Ti-Max X]

04560264560673X-SG65
04560264560529X-SG65L
04560264560253X-DSG20
04560264560246X-DSG20L
04560264560192X-SG25L
04560264560185X-SG93
04560264560086X-SG93L
04560264560079X-SG20L
04560264557093X-SG20L
04560264533257X-SG65
04560264528499X-DSG20Lh
04560264528482X-DSG20h
04560264528475X-DSG20L
04560264528468X-DSG20
04560264518575X-SG65L
04560264518513X-SG25L
04560264517912X-SG93
04560264517905X-SG93L
04560264516953X-SG20L
04560264516878X500KL
04560264510906X55
04560264510890X55L
04560224993183X500KL
04560224993138X500L
04560264530768X95EX
04560264510944X35
04560264510937X35L
04560264510920X57
04560264510913X57L
04560264523692X600WLED

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