DEVICE: HOPKINS (04048551094433)
Device Identifier (DI) Information
HOPKINS
28132BVA
In Commercial Distribution
Karl Storz GmbH & Co. KG
28132BVA
In Commercial Distribution
Karl Storz GmbH & Co. KG
HOPKINS® Telescope 30°, 4 mm, 18 cm
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 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWG | ENDOSCOPE, NEUROLOGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K982837 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Ethylene Oxide |
Moist Heat or Steam Sterilization |
Hydrogen Peroxide |
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
398c65f7-8017-4915-b054-0b11f0e01dee
July 06, 2018
4
September 23, 2016
July 06, 2018
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined