DEVICE: INSTRUMENT (07613327207835)
Device Identifier (DI) Information
INSTRUMENT
0580-4450-3
In Commercial Distribution
0580-4450-3
Howmedica Osteonics Corp.
0580-4450-3
In Commercial Distribution
0580-4450-3
Howmedica Osteonics Corp.
EXETER MODULAR RASP
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 |
---|---|
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 |
---|---|
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
KWL | Prosthesis, hip, hemi-, femoral, metal |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
HWC | Screw, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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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Device Size Text, specify: Size: 3 |
Device Size Text, specify: Offset: 50.0 Millimeter |
Device Record Status
5543215e-086d-4dd8-9291-22e627182f17
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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