EPIONE RoboKit Plus

Primary DI
03760305400253
Brand
EPIONE RoboKit Plus
Company
QUANTUM SURGICAL
Model
09-0046
Device description
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®. Sterile drapes are used to cover: the robotic arm, the touchscreen of the display cart, the tray of the display cart supporting the mouse and the keyboard. Reflective spheres to be placed on the tracked EPIONE instruments tracked. The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
Published
2024-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760305400253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760305400253037603054002533760305400253

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical tracking system spatial marker, single-useA non-powered, noninvasive component of a surgical navigation and/or tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device.

Regulatory Flags#

DUNS number
268397609
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
03760305400260EPIONE RoboKit09-00572024-12-12
03760305400031EPIONE30-0001 v1.0.22023-05-25
03760305400024Patient Reference02-002602-00262022-09-09
03760305400055Navigation probe02-003102-00312022-09-09
03760305400062Needle Guide02-002702-0027-19G2022-09-09
03760305400079Short Navigation Probe02-004402-00442022-09-09
03760305400086EPIONE30-0001 30-0001-01-USA2022-09-09

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