DEVICE: Accu-Beam (B1773181AS50010)

Device Identifier (DI) Information

Accu-Beam
3181AS5-001
In Commercial Distribution

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
B1773181AS50010
HIBCC

1
130213366 *Terms of Use
Stryker EndoAdapter with Stem, 5mm.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
HHR Laser, Surgical, Gynecologic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

50ed69f6-a6ad-40e8-acd2-c899cf9bea54
March 29, 2018
2
July 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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