DEVICE: DELTA (07613252286417)
Device Identifier (DI) Information
DELTA
73-72284
In Commercial Distribution
73-72284
Stryker Leibinger GmbH & Co. KG
73-72284
In Commercial Distribution
73-72284
Stryker Leibinger GmbH & Co. KG
S-DRILLING TAP, DENT, FOR 4mm SCREW
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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 tap, single-use, non-sterile | A non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device intended to be sterilized prior to use. |
FDA Product Code
[?]Product Code | Product Code Name |
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DZJ | DRIVER, WIRE, AND BONE DRILL, MANUAL |
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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Length: 50.0 Millimeter |
Device Size Text, specify: Diameter: 2.2 Millimeter |
Device Record Status
5ce6c137-6e1f-46f9-b6da-8150167e0348
March 29, 2018
2
August 24, 2016
March 29, 2018
2
August 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 |
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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