Identity
- Trade Name
- CrossGlide ETS FDA UDI
- Generic Name
- Endometrial biopsy kit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CBPN3001 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850012760054 FDA UDI
- 510(k) Number
- K192534 FDA UDI
- FDA Product Code
- HHK FDA UDI
- GMDN Term
- Endometrial biopsy kit 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 kit
CrossGlide ETS by Crossbay Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endometrial biopsy kit.
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- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- Suresample, Endometrial Sampler — GYNEX CORPORATION · Class II
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 23a65bb5-c7d0-488c-bdaf-1f50d82bcc5c 34 fields · synced May 30, 2026