Identity
- Trade Name
- EZDilate FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- Uro-EZDilate KIT 12Fr (4mm) x 4cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE FDA UDI
- Model / Reference
- BURS0404K FDA UDI
- Description
- Uro-EZDilate KIT 12Fr (4mm) x 4cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925033054 FDA UDI
- 510(k) Number
- K132181 FDA UDI
- FDA Product Code
- KOE FDA UDI
- GMDN Term
- Nephrostomy catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5520 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: Nephrostomy catheter
EZDilate by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nephrostomy catheter.
- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
- Flexima™ — Boston Scientific · Class I
- Nephro-Cath Nephrostomy Drainage Catheter — Uresil Corp. · Class I
- Malecot — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Kolibri — Coloplast A/S · U
- Total Abscession — ANGIODYNAMICS, INC · Class I
- Percuflex™ — Boston Scientific · Class II
Cleared under the same submission
K132181 also covers:
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- EZDilate — Gyrus Acmi, Inc.
- Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER — Gyrus Acmi, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI a525d7a2-3e41-42f4-a693-1cf488c0686f 34 fields · synced May 30, 2026