Identity
- Trade Name
- EZDilate FDA UDI
- Generic Name
- Intrauterine haemostatic balloon catheter FDA UDI
- Device Name
- EZDilate 3-Stage Balloon Dilator (Wire Guided) 13.5-14.5-15.5 mm diameter FDA UDI
- Model / Reference
- BD-410X-1555 FDA UDI
- Description
- EZDilate 3-Stage Balloon Dilator (Wire Guided) 13.5-14.5-15.5 mm diameter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925033252 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Intrauterine haemostatic balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 FDA UDI
- Commercial Distribution
- Not 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
EZDilate by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 42d9a554-c4f3-42a1-92e6-ff96b5986016 34 fields · synced May 30, 2026