MulTipeg™ Driver 55003

GUDID 07350096321033

Integration Diagnostics Sweden AB

Multimeter
Primary Device ID07350096321033
NIH Device Record Key93ccc51a-3b8e-4df7-b544-cb5114f3cb4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulTipeg™ Driver
Version Model NumberMulTipeg™ Driver
Catalog Number55003
Company DUNS352736781
Company NameIntegration Diagnostics Sweden AB
Device Count1
DM Exempttrue
Pre-market Exempttrue
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
GS107350096321033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


[07350096321033]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-09
Device Publish Date2022-03-01

Devices Manufactured by Integration Diagnostics Sweden AB

07350096320272 - Osseo 100+2024-11-07
07350096320425 - Penguin MDI2023-12-29
07350096320432 - MulTipeg™2023-12-29
07350096320449 - Penguin MDI2023-12-29
07350096320340 - Penguin II2023-12-28
07350096320043 - Penguin RFA2022-03-16
07350096320050 - Penguin RFA2022-03-16
07350096320067 - Penguin RFA2022-03-16

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