DEVICE: n.a. (04048551098547)
Device Identifier (DI) Information
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 |
---|---|
Neurological endoscope holder | A device intended to be used to hold and fix in position a rigid or flexible endoscope during a diagnostic or therapeutic neurological procedure. It is typically made of high-grade stainless steel and anodized aluminium and will usually be affixed to the operating/examination table enabling the surgeon to freely use both hands. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
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GWG | ENDOSCOPE, NEUROLOGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K982837 | 000 |
Sterilization
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
4e3ad47b-67f0-40d2-8142-7973d9d0d245
July 06, 2018
3
September 23, 2016
July 06, 2018
3
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