FDA UDI
In Commercial Distribution
🇺🇸 United States
CrossGlide ETS
DI: 00850012760054
·
Model: CBPN3001
·
CROSS BAY MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CrossGlide ETS
- Primary DI
- 00850012760054
- Version / Model
- CBPN3001
- Company Name
- CROSS BAY MEDICAL, INC.
- Labeler DUNS
- 065552991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-18
- Public Version
- 1
- Public Version Date
- 2021-10-26
- Public Version Status
- New
- Public Device Record Key
- 23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | Obstetrics/Gynecology | 884.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11531 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012760054 | GS1 | ||||
| Package | 10850012760051 | GS1 | Shelf carton | 5 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192534 | 000 |