DEVICE: ICONIX (07613252450382)
Device Identifier (DI) Information
ICONIX
3910-500-553
In Commercial Distribution
3910-500-553
STRYKER CORPORATION
3910-500-553
In Commercial Distribution
3910-500-553
STRYKER CORPORATION
1.4MM ICONIX 12¿ GUIDE
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
No | |
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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? |
---|---|---|---|---|
35095 | Surgical drill guide, reusable |
A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NBH | ACCESSORIES,ARTHROSCOPIC |
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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Device Size Text, specify: Diameter: 1.4 Millimeter |
Angle: 12.0 degree |
Device Record Status
6d9900e8-5d38-4777-90ae-1dc863d582ce
April 06, 2020
4
September 04, 2015
April 06, 2020
4
September 04, 2015
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
[?]
+1(866)624-4422
xx@xx.xx
xx@xx.xx