Duns Number:122561087
Device Description: BD FocalPoint Refurbished (120V)
Catalog Number
491090
Brand Name
BD FocalPoint Slide Profiler Refurbished
Version/Model Number
491090
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P950009
Product Code
MNM
Product Code Name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Public Device Record Key
b0d8e8e8-ca82-41b6-b3b3-c28cfe5c66f3
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
June 27, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |