N/A 90-2045

GUDID 00850309007022

Classic Dental System

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric
Primary Device ID00850309007022
NIH Device Record Key20ff96a5-1633-4f2d-aad2-74702da9f3d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number90-2045
Catalog Number90-2045
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

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850309007022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

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

On-Brand Devices [N/A]

00850309007053Designer Dental System
00850309007046Designer Assistant's System
00850309007039Designer Assistant's System
00850309007022Classic Dental System
00850309007015Classic Assistant's System
00850309007008Classic Assistant's System

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