DEVICE: EPIC SMALL STAPLE (00817577023192)
Device Identifier (DI) Information
EPIC SMALL STAPLE
A
In Commercial Distribution
3100-0000
Exactech, Inc.
A
In Commercial Distribution
3100-0000
Exactech, Inc.
Small Staple Instrument
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
10458 | Orthopaedic bone staple driver |
A hand-held surgical instrument designed to impart force on a bone staple, or on another instrument, to insert the bone staple typically into fractured bone. The distal end is typically shaped to mate with the bone staple. The proximal end is designed to absorb and transmit an impact force. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDR | Staple, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K163226 | 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
0647eac6-58df-49c6-907a-9de34a06ad3c
December 17, 2019
2
October 31, 2018
December 17, 2019
2
October 31, 2018
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