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.

Endometrial biopsy kit

• Primary Device ID: 00850012760054
• NIH Device Record Key: 23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CrossGlide ETS
• Version Model Number: CBPN3001
• Company DUNS: 065552991
• Company Name: CROSS BAY MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012760054 [Primary]
GS1	10850012760051 [Package]; Package: Shelf carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192534

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-26
• Device Publish Date: 2021-10-18

Devices Manufactured by CROSS BAY MEDICAL, INC.

• 00850012760054 - CrossGlide ETS: 2021-10-26The 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 ETS: 2021-10-26 The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membr
• 00850012760061 - CrossGlide: 2021-07-23 The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting