Identity
- Trade Name
- CrossGlide FDA UDI
- Generic Name
- Endometrial biopsy curette FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- ETS Plus FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- CBPN3003 FDA UDI
- Primary DI / UDI-DI
- 00850012760061 FDA UDI
- FDA Product Code
- HHK FDA UDI
- GMDN Term
- Endometrial biopsy curette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endometrial biopsy curette
CrossGlide by Crossbay Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Crossbay Medical
Sources (1)
- FDA UDI c4cb2ee4-3b69-4c08-a1b8-37cf89e554c5 36 fields · synced May 30, 2026