Penguin II 55241

GUDID 07350096320340

Integration Diagnostics Sweden AB

Multimeter
Primary Device ID07350096320340
NIH Device Record Key81f380c3-df6a-417e-98de-2801deab8ed2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePenguin II
Version Model NumberPenguin II Instrument
Catalog Number55241
Company DUNS352736781
Company NameIntegration Diagnostics Sweden AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350096320333 [Primary]
GS107350096320340 [Package]
Contains: 07350096320333
Package: PenguinIISet Klockne [1 Units]
In Commercial Distribution
GS107350096320371 [Package]
Contains: 07350096320333
Package: Penguin II Demo Set [1 Units]
In Commercial Distribution
GS107350096320456 [Package]
Contains: 07350096320333
Package: IS4 Instrument Set [1 Units]
In Commercial Distribution
GS107350096320463 [Package]
Contains: 07350096320333
Package: PenguinIISet Citagen [1 Units]
In Commercial Distribution
GS107350096320470 [Package]
Contains: 07350096320333
Package: PenguinIISet Bredent [1 Units]
In Commercial Distribution
GS107350096320487 [Package]
Contains: 07350096320333
Package: PenguinIISet NucleOS [1 Units]
In Commercial Distribution
GS107350096320494 [Package]
Contains: 07350096320333
Package: PenguinIISet ABdenta [1 Units]
In Commercial Distribution
GS107350096320531 [Package]
Contains: 07350096320333
Package: Penguin II Set SIC [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

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
07350096320340 - Penguin II2023-12-28
07350096320043 - Penguin RFA2022-03-16
07350096320050 - Penguin RFA2022-03-16
07350096320067 - Penguin RFA2022-03-16

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