DEVICE: ENDOPLASTIC SCOPE (B089B659210)

Device Identifier (DI) Information

ENDOPLASTIC SCOPE
B65921
In Commercial Distribution
B65921
BLACK & BLACK SURGICAL, INC.
B089B659210
HIBCC

1
004382282 *Terms of Use
ENDOPLASTIC SCOPE; 7''(17.5CM), 30 DEGREE, 4MM DIAMETER,
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Rigid arthroscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HRX Arthroscope
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K943426 000
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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

819b50ce-7a4f-4da3-ab27-03a83c9fb7d7
July 06, 2018
3
September 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
877-252-2517
info@blackandblacksurgical.com
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