DEVICE: INSTRUMENT (07613327207750)
Device Identifier (DI) Information
INSTRUMENT
0580-375-2
In Commercial Distribution
0580-375-2
Howmedica Osteonics Corp.
0580-375-2
In Commercial Distribution
0580-375-2
Howmedica Osteonics Corp.
EXETER MODULAR RASP
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35559 | Bone file/rasp, manual, reusable |
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
KWL | Prosthesis, hip, hemi-, femoral, metal |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
HWC | Screw, fixation, bone |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
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 |
---|
Device Size Text, specify: Offset: 37.5 Millimeter |
Device Size Text, specify: Size: 2 |
Device Record Status
b328728d-0fb8-4e5a-b416-1d1b673ace5e
October 31, 2022
5
September 24, 2016
October 31, 2022
5
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 |
---|---|
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