DEVICE: Accu-Beam (B17731250)
Device Identifier (DI) Information
Accu-Beam
3125
In Commercial Distribution
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
3125
In Commercial Distribution
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Fixed focus lens assembly for single puncture set, f400mm.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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. 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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18027 | Laparoscope laser coupler |
A device used to connect a laser delivery system [e.g., the articulating arm of a carbon dioxide (CO2) laser] and a laparoscope; providing a coincidence between the aiming beam and the treatment beam at the target site. It typically consists of a lens housing including a set of lenses, a laparoscope adaptor, and a sleeve. It is attached to the laser delivery system at the proximal end and to the laparoscope at the distal end, and the sleeve is placed inside the working channel of the laparoscope to provide a path for the laser. The device is typically used for a procedure using a laser type which wavelength is not appropriate for fibreoptic cable transmission. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HHR | Laser, Surgical, Gynecologic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K870046 | 000 |
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
3a3af78f-378a-4f1c-84ec-f86accab6afb
July 19, 2021
4
July 06, 2016
July 19, 2021
4
July 06, 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
[?]
No Customer Contact currently defined