Duns Number:801895244
Device Description: Endometrial Sampling Device
Catalog Number
-
Brand Name
SelectCells Mini
Version/Model Number
SM203
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
K954097,K954097
Product Code
HHK
Product Code Name
Curette, Suction, Endometrial (And Accessories)
Public Device Record Key
d8f0d29f-f860-4507-a8d0-987f1582fa5e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2016
Package DI Number
20888937011221
Quantity per Package
25
Contains DI Package
00888937011227
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 |