Malleable Ear Dressing

FDA UDI

Class I (US FDA UDI)

by Invotec International, Inc.

Identity

Trade Name: Malleable Ear Dressing FDA UDI
Generic Name: Intranasal splint, non-biodegradable FDA UDI
Device Name: Malleable Ear Dressing, Aluminum/Silicone FDA UDI
Model / Reference: 90-20000 FDA UDI
Description: Malleable Ear Dressing, Aluminum/Silicone FDA UDI

Identifiers

Catalog Number: 90-20000 FDA UDI
Primary DI / UDI-DI: 00818501021154 FDA UDI
FDA Product Code: ITG FDA UDI
GMDN Term: Intranasal splint, non-biodegradable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3025 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Intranasal splint, non-biodegradable

Malleable Ear Dressing by Invotec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splint, non-biodegradable.

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Sterile Gauze Sponges — JIANGSU FEIXIA MEDICAL PRODUCTS CO., LTD · Class I
Sterile Pad 9cm x 15cm one fold Without X-Ray ETO sterile — ERMED TIP MEDİKAL TİCARET A.Ş. · Class IIa
Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
Custom Nasal Splint — Boston Medical Products, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Invotec International, Inc.

Sources (1)

FDA UDI 039c3cc6-d71b-4b95-a2c3-6b697e5c86a6 34 fields · synced Jun 9, 2026