FDA.reportPublic FDA data

Dexter Endoscope Arm

Primary DI
04260463844993
Brand
Dexter Endoscope Arm
Company
Aktormed GmbH
Model
212499
Catalog number
212499
Device description
customized SOLOASSIST II for Dexter, incl. Power supply and supply cable
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
04260463844993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463844993042604638449934260463844993

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

Contacts#

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

Regulatory Flags#

DUNS number
537223815
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04260463845907ENDOSCOPE CLAMP2225902225902024-10-01
04260463844276Joystick RH - IIA2024272022-04-12
04260463845433Joystick LH-US2125432022-04-12
04260463845440Joystick RH-US2125442022-04-12
04260463840919JOYSTICK-LH1720912021-04-29
04260463840650MOUNT-1B1720652021-04-29
04260463840667MOUNT-1A1720662021-04-29
04260463840674MOUNT-2A1720672021-04-29
04260463840681MOUNT-2B1720682021-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260463845181PROBE PINAktormed GmbHQZB2024-10-02
04260463842821STERILISATION TRAY XLAktormed GmbHQZB2024-10-01
04260463844801CANTILEVERAktormed GmbHQZB2024-10-01
04260463844825JOINTAktormed GmbHQZB2024-10-01
04260463845907ENDOSCOPE CLAMPAktormed GmbHQZB2024-10-01
03770025849096Maestro SystemMoon Surgical IncQZB2024-09-03