FDA.reportPublic FDA data

BUNDLE JOYSTICK-RH-US

Primary DI
04260463845341
Brand
BUNDLE JOYSTICK-RH-US
Company
Aktormed GmbH
Model
212534
Device description
consisting of: 1x joystick-RH (Art.212544) 1x sterile cover PU/50 ea. (Art.110084)
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QZBSoftware Controlled Endoscope And Instrument Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZBSoftware Controlled Endoscope And Instrument HolderGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233312000SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894Aktormed GmbH2024-08-08QZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260463845341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463845341042604638453414260463845341

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA non-powered device designed to hold or stabilize a video camera or endoscope (e.g., to a table or rail) while recording a surgical operative procedure. This is a reusable device.

Regulatory Flags#

DUNS number
537223815
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260463842357Sterile Set1822352026-09-04
04260463844269ARTip solo2024262026-09-04
04260463844290SET ARTip solo voice2024292026-09-04
04260463844450ARTip solo voice2024452026-09-04
04260463845334BUNDLE JOYSTICK-LH-US2125332026-09-04
14260463842064Power Cord C13182206 (US)2026-09-04
04260463842333ENDOSCOPE CLAMP A1822332026-02-25
04260463845273STERILISATION TRAY1415272026-02-25
04260463846867ENDOSCOPE CLAMP B1516862026-02-25
04260463849066CONTROL1719062026-02-25
04260463849127ENDOFIX EXO SET1719122026-02-25
04260463849271CONE ADAPTER1719272026-02-25
04260463849431Endofix EXO1719432025-07-30
04260463845181PROBE PIN2125182125182024-10-02
04260463842821STERILISATION TRAY XL1922821922822024-10-01
04260463844801CANTILEVER2124802124802024-10-01
04260463844825JOINT2124822124822024-10-01
04260463844993Dexter Endoscope Arm2124992124992024-10-01
04260463845907ENDOSCOPE CLAMP2225902225902024-10-01
04260463844276Joystick RH - IIA2024272022-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260463842357Sterile SetAktormed GmbHQZB2026-09-04
04260463844269ARTip soloAktormed GmbHQZB2026-09-04
04260463845334BUNDLE JOYSTICK-LH-USAktormed GmbHQZB2026-09-04
04260463845181PROBE PINAktormed GmbHQZB2024-10-02
04260463842821STERILISATION TRAY XLAktormed GmbHQZB2024-10-01
04260463844801CANTILEVERAktormed GmbHQZB2024-10-01
04260463844825JOINTAktormed GmbHQZB2024-10-01
04260463844993Dexter Endoscope ArmAktormed GmbHQZB2024-10-01
04260463845907ENDOSCOPE CLAMPAktormed GmbHQZB2024-10-01
03770025849096Maestro SystemMoon Surgical IncQZB2024-09-03