Duns Number:801895244
Device Description: Medscand® Sample Collection Kit for use with The ThinPrep® Pap Test™Cytobrush® Plus GT • P Medscand® Sample Collection Kit for use with The ThinPrep® Pap Test™Cytobrush® Plus GT • Pap-Perfect® Plastic Spatula
Catalog Number
-
Brand Name
Medscand® Sample Collection Kit
Version/Model Number
02500
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
Yes
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
K861389,K861389
Product Code
HHT
Product Code Name
Spatula, Cervical, Cytological
Public Device Record Key
134ed6e4-a7ab-4eed-ab79-16ce25105692
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 2017
Package DI Number
20888937010958
Quantity per Package
20
Contains DI Package
60888937010956
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |