Duns Number:903963889
Device Description: "Cervical Sample Collection Kit, intended for collection of cytological specimens from the "Cervical Sample Collection Kit, intended for collection of cytological specimens from the ectocervix andthe endocervix."
Catalog Number
-
Brand Name
KOLPLAST
Version/Model Number
Standard
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153128
Product Code
HHT
Product Code Name
Spatula, Cervical, Cytological
Public Device Record Key
6a5cb172-69e3-4a5c-9426-71b0adfd35ab
Public Version Date
September 23, 2019
Public Version Number
1
DI Record Publish Date
September 13, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |