CrossGlide CBPN3003
GUDID 00850012760061
The CrossGlide Endometrial Tissue Sampler (ETS Plus) 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 curette| Primary Device ID | 00850012760061 |
| NIH Device Record Key | c4cb2ee4-3b69-4c08-a1b8-37cf89e554c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CrossGlide |
| Version Model Number | ETS Plus |
| Catalog Number | CBPN3003 |
| 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 |
Customer Support Contacts
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com | |
| Phone | 844-722-6162 |
| info@crossbaymedicalinc.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012760061 [Primary] |
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 | 2021-07-23 |
| Device Publish Date | 2021-07-15 |
Devices Manufactured by CROSS BAY MEDICAL, INC.
| 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 | 2021-07-23The CrossGlide Endometrial Tissue Sampler (ETS Plus) 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. |
| 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 |
Trademark Results [CrossGlide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSSGLIDE 88547107 not registered Live/Pending |
CrossBay Medical, Inc. 2019-07-29 |
 CROSSGLIDE 85701005 not registered Dead/Abandoned |
Guthy-Renker LLC 2012-08-10 |
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