Ultra DC Oral Surgery Package C 46200-OS

GUDID 00813830025538

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer
Primary Device ID00813830025538
NIH Device Record Keyc1174b92-e9af-4b8f-9735-1282c076e76a
Commercial Distribution Discontinuation2099-04-10
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra DC Oral Surgery Package C
Version Model Number46200-OS
Catalog Number46200-OS
Company DUNS088302096
Company NameACCUTRON, 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100813830025538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSZGas-Machine, Anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-18
Device Publish Date2019-04-10

On-Brand Devices [Ultra DC Oral Surgery Package C]

0081383002312146200OS
0081383002553846200-OS

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