DEVICE: Accu-Beam (B17770040)

Device Identifier (DI) Information

Accu-Beam
7004
In Commercial Distribution

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
B17770040
HIBCC

1
130213366 *Terms of Use
General use micromanipulator for articulated arm CO2 lasers.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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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
Laser adaptor A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. 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 [?]
K864378 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

975b3fa5-2a72-4b9b-9b91-d8fd497a6c41
July 06, 2018
4
May 12, 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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Yes
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No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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