DEVICE: n.a. (04048551103739)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical irrigation/aspiration handpiece, reusable | A hand-held device designed to regulate and direct a stream of pressurized, warmed fluid (e.g., sterile water or saline) and alternatively provide aspiration (suction) to a surgical site for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. 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
bbf3aebd-9124-4bc7-ad32-4a47ac39ba59
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 |
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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