DEVICE: Accu-Beam (B17791140)

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Device Identifier (DI) Information

Accu-Beam
9114

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
B17791140
HIBCC
1
Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 15cm, 16ga, ID 1.1mm.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
General/multiple surgical laser system beam guide, reusable A flexible, probe-like device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It typically consists of fibreoptic materials with an invasive laser-firing distal end. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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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 Status

In Commercial Distribution
May 20, 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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