DEVICE: Versajet (00040565124759)
Device Identifier (DI) Information
Versajet
66800039
In Commercial Distribution
66800039
SMITH & NEPHEW MEDICAL LIMITED
66800039
In Commercial Distribution
66800039
SMITH & NEPHEW MEDICAL LIMITED
Versajet II Hydrosurgery System Console
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36961 | Water jet knife system generator |
A mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FQH | Lavage, Jet |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K143115 | 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
9ca5e57b-e0be-4d7f-8042-c372f7c0502d
September 07, 2023
6
September 20, 2016
September 07, 2023
6
September 20, 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