DEVICE: AcuSpot 712 Z Micromanipulator (07290109141954)
Device Identifier (DI) Information
AcuSpot 712 Z Micromanipulator
AcuSpot 712 Z Micromanipulator
In Commercial Distribution
AC-0020170
LUMENIS LTD.
AcuSpot 712 Z Micromanipulator
In Commercial Distribution
AC-0020170
LUMENIS LTD.
Additional DM DIs:
07290109144306
07290109144313
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58210 | ENT surgery micromanipulator |
A mains electricity (AC-powered) device designed for accurate manipulation of microscopic objects during ears/nose/throat (ENT) microsurgery (e.g., middle ear laser stapedotomy) usually by making small movements under the visual field of a surgical microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, small forceps). The device does not perform its actions following a computerized program.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b08f34e0-bb37-41c9-b771-e38892b975ac
January 17, 2024
7
September 13, 2016
January 17, 2024
7
September 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
408-764-3000
xxx@xxx.xxx
xxx@xxx.xxx