Duns Number:065552991
Device Description: The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter w The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and evertingmembrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplyingsaline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Cathetercontains an acorn tip as an aid in seating its distal end at the exocervix.
Catalog Number
CBPN3003
Brand Name
CrossGlide
Version/Model Number
ETS Plus
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
-
Product Code
HHK
Product Code Name
Curette, Suction, Endometrial (And Accessories)
Public Device Record Key
c4cb2ee4-3b69-4c08-a1b8-37cf89e554c5
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
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. | 1 |