SOLOASSIST II Set

GUDID 04260463849103

Set consisting of - 1x Power supply with power cord US (172035 + 172054) - 1x Supply cable (172054) - 1x SOLOASSIST II (141364) - 1x Trolley (120874) - 1x Operating Instruction

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 ID: 04260463849103
• NIH Device Record Key: 220892e8-76cc-4cda-9548-b6036f101969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLOASSIST II Set
• Version Model Number: 171910
• Company DUNS: 537223815
• Company Name: Aktormed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260463849103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171947

FDA Product Code

• NAY: System, Surgical, Computer Controlled Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-22
• Device Publish Date: 2019-10-14

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 - IIA: 2022-04-20
• 04260463845433 - Joystick LH-SYK: 2022-04-20
• 04260463845440 - Joystick RH-SYK: 2022-04-20
• 04260463840919 - JOYSTICK-LH: 2021-08-31
• 04260463840650 - MOUNT-1B: 2021-05-07
• 04260463840667 - MOUNT-1A: 2021-05-07
• 04260463840674 - MOUNT-2A: 2021-05-07