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TruDi Curette

FDA UDI

Class II (US FDA UDI)

by Acclarent, Inc.

Identity

Trade Name
TruDi Curette FDA UDI
Generic Name
Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI
Device Name
TruDi Curette, 0°, 5IN - 1PK FDA UDI
Model / Reference
TDC0005Z FDA UDI
Description
TruDi Curette, 0°, 5IN - 1PK FDA UDI

Identifiers

Catalog Number
TDC0005Z FDA UDI
Primary DI / UDI-DI
20705031465432 FDA UDI
510(k) Number
K201174 FDA UDI
FDA Product Code
PGW FDA UDI
GMDN Term
Surgical soft-tissue manipulation forceps, scissors-like, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical soft-tissue manipulation forceps, scissors-like, single-use

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

Similar devices

Also classified as Surgical soft-tissue manipulation forceps, scissors-like, single-use.

Cleared under the same submission

K201174 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acclarent, Inc.

Sources (1)

  • FDA UDI 218691ad-86a3-477d-9b01-b623648ccb32 37 fields · synced May 31, 2026