FDA.reportPublic FDA data

SET ARTip solo voice

Primary DI
04260463844290
Brand
SET ARTip solo voice
Company
Aktormed GmbH
Model
202429
Device description
Set consiting of: 1x ARTip solo voice (202445) 1x Headset (171882) 1x Power Cord C13 (182206) 1x Connection Cable (171896) 1x Charger Headset 1x Y-Line (171895)
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
NAYSystem, Surgical, Computer Controlled Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260463844290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260463844290042604638442904260463844290

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
true
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
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
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
04260463844269ARTip soloAktormed GmbHNAY2026-09-04
04260463844450ARTip solo voiceAktormed GmbHNAY2026-09-04
14260463842064Power Cord C13Aktormed GmbHNAY2026-09-04
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14
00886874123447EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874120736Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00886874120743Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00815440021924SenhanceAsensus Surgical, Inc.NAY2023-09-19
00815440021825SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440021856SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022235SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022242SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022259SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022280SenhanceAsensus Surgical, Inc.NAY2022-07-11
00886874121917SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121924SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121931SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121474EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121511EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121528EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00815440021931SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022075SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022082SenhanceAsensus Surgical, Inc.NAY2020-08-05
00886874119792EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119808EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874120767EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119136EndoWrist;daVinci SiINTUITIVE SURGICAL, INC.NAY2020-02-19