DEVICE: SynFix (10705034709581)
Device Identifier (DI) Information
SynFix
SD397.161
In Commercial Distribution
SD397161
SYNTHES (U.S.A.) LP
SD397.161
In Commercial Distribution
SD397161
SYNTHES (U.S.A.) LP
SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 11MM
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 |
---|---|
Bone rasp | A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HTR | RASP |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d5225a4a-07a4-410f-8769-dea9bf3158d9
March 29, 2018
2
December 31, 2016
March 29, 2018
2
December 31, 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 |
---|---|
HIBCC | H981SD3971610 |
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
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx