DEVICE: TwinLoop FLEX (04546540678270)
Device Identifier (DI) Information
TwinLoop FLEX
3910-400-105
In Commercial Distribution
3910-400-105
STRYKER CORPORATION
3910-400-105
In Commercial Distribution
3910-400-105
STRYKER CORPORATION
TWINLOOP FLEX 25 DEG. GUIDE
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 |
---|---|
Surgical drill guide, reusable | A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It 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 at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill size, is made of high-grade stainless steel, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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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Angle: 25.0 degree |
Device Record Status
308c3169-1103-4dbf-b518-38d74e9a137f
March 29, 2018
2
September 04, 2015
March 29, 2018
2
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 |
---|---|---|---|---|---|
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