DEVICE: Biosteon IntraLine (07613252293187)
Device Identifier (DI) Information
Biosteon IntraLine
3910-002-045
In Commercial Distribution
3910-002-045
STRYKER CORPORATION
3910-002-045
In Commercial Distribution
3910-002-045
STRYKER CORPORATION
4.5MM BIOSTEON INTRALINE PUNCH TAP
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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, reusable | A 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 reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWX | TAP, BONE |
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: Diameter: 4.5 Millimeter |
Device Record Status
40a8ba30-ef78-4ac3-a06c-39c0cc38bfea
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 |
---|---|
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