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Dornier MedTech

FDA UDI

Class II (US FDA UDI)

by Dornier MedTech America, Inc.

Identity

Trade Name
Dornier MedTech FDA UDI
Generic Name
Urethral dilator, single-use FDA UDI
Device Name
Equinox Ureteral Dilatation Balloon, 4mm x 10cm Kit FDA UDI
Model / Reference
Equinox Ureteral Dilatation Balloon, 4mm x 10cm Kit FDA UDI
Description
Equinox Ureteral Dilatation Balloon, 4mm x 10cm Kit FDA UDI

Identifiers

Catalog Number
EQD0410K FDA UDI
Primary DI / UDI-DI
00810116021451 FDA UDI
FDA Product Code
EZN FDA UDI
KOE FDA UDI
GMDN Term
Urethral dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5470 FDA UDI
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

No

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: Urethral dilator, single-use

Dornier MedTech by Dornier MedTech America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA UDI f0c665ec-f14d-4d53-9331-073448882058 34 fields · synced Jun 9, 2026