DEVICE: ColpoSlad 726 Micromanipulator (07290109141787)
Device Identifier (DI) Information
ColpoSlad 726 Micromanipulator
ColpoSlad 726 Micromanipulator
In Commercial Distribution
AA0631700
LUMENIS LTD.
ColpoSlad 726 Micromanipulator
In Commercial Distribution
AA0631700
LUMENIS LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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 |
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GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
4adeb719-dfe3-46a0-98a7-c00e361cdf16
October 10, 2023
5
September 14, 2016
October 10, 2023
5
September 14, 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 |
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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