DEVICE: HOPKINS (04048551091517)

Device Identifier (DI) Information

HOPKINS
28008FA
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551091517
GS1

1
315731430 *Terms of Use
HOPKINS® Telescope 12°, 2 mm, 26 cm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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 fibreoptic neuroscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the central nervous system (CNS). It is inserted into the body through a pre-drilled hole in the cranium for neuroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GWG ENDOSCOPE, NEUROLOGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982837 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
Hydrogen Peroxide
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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

fa5533c5-f3ec-455a-bd50-837fa274d17b
July 06, 2018
4
September 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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No
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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