← Back to catalogue

CUSA® Selector®

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name
CUSA® Selector® FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Device Name
CUSA® Selector® 35 KHz Neurosurgical Handpiece for MRI FDA UDI
Model / Reference
1528020M8 FDA UDI
Description
CUSA® Selector® 35 KHz Neurosurgical Handpiece for MRI FDA UDI

Identifiers

Catalog Number
1528020M8 FDA UDI
Primary DI / UDI-DI
10381780040040 FDA UDI
510(k) Number
K021989 FDA UDI
FDA Product Code
LFL FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

CUSA® Selector® by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K021989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Integra Lifesciences (ireland) Limited

Sources (1)

  • FDA UDI d900c3db-16a1-4dd1-b7cc-d312a82ee57c 39 fields · synced May 30, 2026