Sterile Set

GUDID 04260463849073

consisting of - 1x Endoscope clamp (141363) - 1x Universal joint (141362) - 1x Tension sleeve D10 (141339) - 1x Tension sleeve D5 (141365) - 1x Sterilization tray (141357)

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 ID04260463849073
NIH Device Record Key98746676-3d2d-4b4f-850d-727656de1b4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Set
Version Model Number171907
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 Numberfalse
Manufacturing Datefalse
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
GS104260463849073 [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

04260463840964 - STERILE COVER PU /10 EA.2022-04-20 10x AKTORMED PROBE COVER 30cm X 178cm (00748426105830)
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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