SOLOASSIST II

GUDID 04260463843644

Aktormed GmbH

Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder Surgical camera holder
Primary Device ID04260463843644
NIH Device Record Key2907d328-f51d-46f7-a689-5d6184b04355
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLOASSIST II
Version Model Number141364
Company DUNS537223815
Company NameAktormed GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260463843644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAYSystem, Surgical, Computer Controlled Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-22
Device Publish Date2019-10-14

Devices Manufactured by Aktormed GmbH

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04260463844276 - Joystick RH - IIA2022-04-20
04260463845433 - Joystick LH-SYK2022-04-20
04260463845440 - Joystick RH-SYK2022-04-20
04260463840919 - JOYSTICK-LH2021-08-31
04260463840650 - MOUNT-1B2021-05-07
04260463840667 - MOUNT-1A2021-05-07
04260463840674 - MOUNT-2A2021-05-07

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