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OTOCELL® Ear Wick

FDA UDI

Class I (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
OTOCELL® Ear Wick FDA UDI
Generic Name
Ear wick, non-biodegradable FDA UDI
Device Name
Size: 8 x 15 mm; Type: Fenestrated FDA UDI
Model / Reference
EW-815F FDA UDI
Description
Size: 8 x 15 mm; Type: Fenestrated FDA UDI

Identifiers

Catalog Number
EW-815F FDA UDI
Primary DI / UDI-DI
EBESEW815F0 FDA UDI
FDA Product Code
KCN FDA UDI
GMDN Term
Ear wick, non-biodegradable 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 15 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI

Category: Ear wick, non-biodegradable

OTOCELL® Ear Wick by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear wick, non-biodegradable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI 5bd6d003-20f4-4d2e-84e3-19a1c56b8288 37 fields · synced Jun 9, 2026