CrossGlide ETS
- Primary DI
- 00850012760054
- Brand
- CrossGlide ETS
- Company
- CROSS BAY MEDICAL, INC.
- Model
- CBPN3001
- Device description
- 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.
- Published
- 2021-10-18
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K192534 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850012760051 | Package | GS1 | 5 | In Commercial Distribution |
| 00850012760054 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10850012760051 | 10850012760051 | ||
| 00850012760054 | 00850012760054 | 850012760054 | 0850012760054 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endometrial biopsy kit | A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 065552991
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850012760061 | CrossGlide | ETS Plus | CBPN3003 | 2021-07-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06974500612718 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612725 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612732 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612749 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612756 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612763 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612770 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612787 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612794 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612824 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612831 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
| 06974500612848 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
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| 06974500612886 | Rigid Uterine Aspiration Curette | GCMEDICA ENTERPRISE LTD.(WUXI) | HHK | 2026-05-18 |
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