DEVICE: Symmetry WILDE (00887482022283)
Device Identifier (DI) Information
Symmetry WILDE
53-1280
In Commercial Distribution
53-1280
SYMMETRY SURGICAL INC.
53-1280
In Commercial Distribution
53-1280
SYMMETRY SURGICAL INC.
Ivd Rongeur Straight #1
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 |
---|---|
Intervertebral disc rongeur | A surgical instrument designed for introduction between the bodies of vertebrae for the removal of the broad and flattened disc of fibrocartilage through a cutting/biting action. It is typically made of high-grade stainless steel and constructed as a long instrument with one sliding and one stationary rod, each having a sharp-edged, scoop-shaped, jaw at the distal end which is activated through two pivoted handles that, when squeezed together, close the jaws to bite (cut) through tissue. It is designed to withstand the forces which are applied in order to bite over such tough tissue whilst having a thin enough profile to enable entry into this narrow space. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAE | Rongeur, Manual |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
21e3579e-fd32-4298-b98e-45d5ca184be9
March 29, 2018
2
May 20, 2016
March 29, 2018
2
May 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