DEVICE: NA (04546540142429)
Device Identifier (DI) Information
NA
01-17840
In Commercial Distribution
01-17840
Stryker Leibinger GmbH & Co. KG
01-17840
In Commercial Distribution
01-17840
Stryker Leibinger GmbH & Co. KG
INTERDENTAL OSTEOTOME, OBWEGESER
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 |
---|---|
Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LRC | INSTRUMENT, ENT MANUAL SURGICAL |
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 |
---|
Width: 3.0 Millimeter |
Length: 15.5 Centimeter |
Device Record Status
9bda7244-fc52-466f-a9c6-291250276d8f
March 29, 2018
2
December 08, 2016
March 29, 2018
2
December 08, 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 |
---|---|---|---|---|---|
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
[?]
No Customer Contact currently defined