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Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER FDA UDI
Generic Name
Ureteral dilatation catheter FDA UDI
Model / Reference
BURS0604K FDA UDI

Identifiers

Primary DI / UDI-DI
00821925033139 FDA UDI
510(k) Number
K132181 FDA UDI
FDA Product Code
KOE FDA UDI
GMDN Term
Ureteral dilatation 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: Ureteral dilatation catheter

Uro-EZDilate KIT 18Fr (6mm) x 4cm URETERAL BALLOON DILATION CATHETER by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K132181 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 55d28766-be38-4fe5-9be0-256fb25d8e5b 33 fields · synced Jun 8, 2026