Duns Number:065552991
Device Description: The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a The CrossGlide Endometrial Tissue Sampler (ETS) 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
-
Brand Name
CrossGlide ETS
Version/Model Number
CBPN3001
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
K192534,K192534
Product Code
HHK
Product Code Name
Curette, Suction, Endometrial (And Accessories)
Public Device Record Key
23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
10850012760051
Quantity per Package
5
Contains DI Package
00850012760054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |