Advanced Dental System 90-2134D

GUDID 00850309007275

Advanced Dental System

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric
Primary Device ID00850309007275
NIH Device Record Keyae79524b-2b0b-484a-9356-51027dd528ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvanced Dental System
Version Model Number90-2134D
Catalog Number90-2134D
Company DUNS808695159
Company NameASI MEDICAL, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850309007275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQYLocator, Root Apex

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

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00850309007237Advanced Dental System
00850309007213Advanced Dental System
00850309007190Advanced Dental System
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