DEVICE: IEC-Innoview GmbH (B192300006000)

Device Identifier (DI) Information

IEC-Innoview GmbH
30-0006-00
In Commercial Distribution
30-0006-00
INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
B192300006000
HIBCC

1
010741028 *Terms of Use
2.7 mm, 70 deg. Arthroscope, l=175mm, autoclavable
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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
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 [?]
K962330 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
Angle: 70 degree
Outer Diameter: 2.7 Millimeter
Length: 175 Millimeter
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Device Record Status

9a256030-aecd-455a-8be7-bafa99a2791f
July 06, 2018
3
May 23, 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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Yes
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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