TruDi Shaver Blade

FDA UDI

Class II (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name: TruDi Shaver Blade FDA UDI
Generic Name: Metal/carbide ENT bur, single-use FDA UDI
Device Name: Trudi Shaver Blade 4.0mm - 60° Curved - 5pk FDA UDI
Model / Reference: TSB460 FDA UDI
Description: Trudi Shaver Blade 4.0mm - 60° Curved - 5pk FDA UDI

Identifiers

Catalog Number: TSB460 FDA UDI
Primary DI / UDI-DI: 10705031469211 FDA UDI
510(k) Number: K221037 FDA UDI
FDA Product Code: PGW FDA UDI
ERL FDA UDI
GMDN Term: Metal/carbide ENT bur, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
874.4250 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Metal/carbide ENT bur, single-use

TruDi Shaver Blade by Acclarent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OSSEOUS Burs-stainless Steel — EON MEDITECH PRIVATE LIMITED · Class I
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Cleared under the same submission

K221037 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Acclarent, Inc.

Sources (1)

FDA UDI 6839df83-fea4-4a9b-9de7-c057ac0c69b7 37 fields · synced Jun 8, 2026