Duns Number:801895244
Device Description: Endometrial Cell Sampler
Catalog Number
-
Brand Name
Wallach Endocell
Version/Model Number
908015
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
K902693,K902693,K902693
Product Code
HFF
Product Code Name
Aspirator, Endometrial
Public Device Record Key
f6d8b10f-1f22-48c6-bced-c4e113c27531
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 16, 2016
Package DI Number
30888937011259
Quantity per Package
210
Contains DI Package
00888937011258
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 |