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SonicOne O.R.

FDA UDI

Class U (US FDA UDI)

by Misonix, LLC

Identity

Trade Name
SonicOne O.R. FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name
SharpVac Debridement Probe with Aspiration FDA UDI
Model / Reference
MXC-C2-VAC FDA UDI
Description
SharpVac Debridement Probe with Aspiration FDA UDI

Identifiers

Primary DI / UDI-DI
00841626101968 FDA UDI
FDA Product Code
LFL FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class
U 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Soft-tissue ultrasonic surgical system handpiece tip, single-use

SonicOne O.R. by Misonix, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue ultrasonic surgical system handpiece tip, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Misonix, LLC

Sources (1)

  • FDA UDI ac1f2b59-2b87-42bf-90ae-78f74018f7eb 33 fields · synced Jun 9, 2026