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Oscar

FDA UDI

Class II (US FDA UDI)

by Orthosonics, Ltd.

Identity

Trade Name
OSCAR FDA UDI
Generic Name
Ultrasonic orthopaedic cement extractor FDA UDI
Device Name
Single Use 6mm Serrated Curved Osteotome – Sterile FDA UDI
Model / Reference
1 FDA UDI
Description
Single Use 6mm Serrated Curved Osteotome – Sterile FDA UDI

Identifiers

Catalog Number
OHC2SO2060SU FDA UDI
Primary DI / UDI-DI
05060201560548 FDA UDI
FDA Product Code
LZV FDA UDI
JDX FDA UDI
GMDN Term
Ultrasonic orthopaedic cement extractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.4580 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

Dimensions & Sizes

Size
Width — 6 Millimeter FDA UDI

Category: Ultrasonic orthopaedic cement extractor

Oscar by Orthosonics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic orthopaedic cement extractor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosonics, Ltd.

Sources (1)

  • FDA UDI 83cd952f-dc48-4382-a10e-a6a30f94f249 36 fields · synced Jun 1, 2026