CrossGlide ETS

GUDID 00850012760054

The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.

CROSS BAY MEDICAL, INC.

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Primary Device ID00850012760054
NIH Device Record Key23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrossGlide ETS
Version Model NumberCBPN3001
Company DUNS065552991
Company NameCROSS BAY MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012760054 [Primary]
GS110850012760051 [Package]
Package: Shelf carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCurette, Suction, Endometrial (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-26
Device Publish Date2021-10-18

Devices Manufactured by CROSS BAY MEDICAL, INC.

00850012760054 - CrossGlide ETS2021-10-26The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.
00850012760054 - CrossGlide ETS2021-10-26 The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membr
00850012760061 - CrossGlide2021-07-23 The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting

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