FDA.reportPublic FDA data

JOINT

Primary DI
04260463844825
Brand
JOINT
Company
Aktormed GmbH
Model
212482
Catalog number
212482
Device description
autoclavable accessories for the DEXTER ENDOSCOPE ARM
Published
2024-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04260463844825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463844825042604638448254260463844825

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4994019320110service@aktormed.com

Regulatory Flags#

DUNS number
537223815
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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
04260463845341BUNDLE JOYSTICK-RH-US2125342026-09-04
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
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
04260463845341BUNDLE JOYSTICK-RH-USAktormed GmbHQZB2026-09-04
04260463845181PROBE PINAktormed GmbHQZB2024-10-02
04260463842821STERILISATION TRAY XLAktormed GmbHQZB2024-10-01
04260463844801CANTILEVERAktormed GmbHQZB2024-10-01
04260463844993Dexter Endoscope ArmAktormed GmbHQZB2024-10-01
04260463845907ENDOSCOPE CLAMPAktormed GmbHQZB2024-10-01
03770025849096Maestro SystemMoon Surgical IncQZB2024-09-03