DEVICE: BD Totalys SlidePrep (00382904913465)
Device Identifier (DI) Information
BD Totalys SlidePrep
491346
In Commercial Distribution
491346
BECTON, DICKINSON AND COMPANY
491346
In Commercial Distribution
491346
BECTON, DICKINSON AND COMPANY
BD Totalys SlidePrep
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 |
---|---|
Microscope slide maker/stainer IVD, automated | A mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MKQ | Processor, Cervical Cytology Slide, Automated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970018 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a37bfa43-3704-4a93-868f-77debeec45ee
July 06, 2018
3
August 25, 2016
July 06, 2018
3
August 25, 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 |
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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
[?]
8006388663
Technical_Services@bd.com
Technical_Services@bd.com