← Back to catalogue

Bionix Development Corporation

FDA UDI

Class I (US FDA UDI)

by Bionix, LLC

Identity

Trade Name
Bionix Development Corporation FDA UDI
Generic Name
Ear canal lavage system FDA UDI
Device Name
Ear Lavage System FDA UDI
Model / Reference
7280 FDA UDI
Description
Ear Lavage System FDA UDI

Identifiers

Catalog Number
7280 FDA UDI
Primary DI / UDI-DI
00859911004146 FDA UDI
FDA Product Code
LRD FDA UDI
GMDN Term
Ear canal lavage system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ear canal lavage system

Bionix Development Corporation by Bionix, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear canal lavage system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bionix, LLC

Sources (1)

  • FDA UDI 2a050dad-15ce-4b04-ac9f-9e8962663410 35 fields · synced May 30, 2026