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Lighted Ear Curette Demo Pack

FDA UDIEUDAMED

Class I (US FDA UDI)

by Bionix, LLC

Identity

Trade Name
Lighted Ear Curette Demo Pack FDA UDI
Generic Name
ENT illuminating foreign body extraction set FDA UDI
Device Name
Lighted Ear Curette Demo Pack FDA UDI
Model / Reference
22200 FDA UDI
Description
Lighted Ear Curette Demo Pack FDA UDI

Identifiers

Catalog Number
22200 FDA UDI
Primary DI / UDI-DI
00714646000545 FDA UDI
FDA Product Code
JYG FDA UDI
GMDN Term
ENT illuminating foreign body extraction set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: ENT illuminating foreign body extraction set

Lighted Ear Curette Demo Pack by Bionix, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as ENT illuminating foreign body extraction set.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bionix, LLC

Sources (2)

  • FDA UDI 03c1c294-ddcd-4cd2-8d8d-4099b4a5f6f8 35 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026