Duns Number:283088573
Device Description: The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
Catalog Number
-
Brand Name
Gynosampler
Version/Model Number
#9164
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
K903002,K903002,K903002
Product Code
HFF
Product Code Name
Aspirator, Endometrial
Public Device Record Key
c96be6b0-7813-4653-b746-1c139e6f4b25
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 04, 2016
Package DI Number
15425017500374
Quantity per Package
25
Contains DI Package
05425017500377
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |