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SONICBEAT 5 mm, 10 cm, Inline Grip

FDA UDI

Class U (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
SONICBEAT 5 mm, 10 cm, Inline Grip FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system holder/tip, single-use FDA UDI
Model / Reference
SB-0510IC FDA UDI

Identifiers

Primary DI / UDI-DI
04953170308970 FDA UDI
510(k) Number
K211838 FDA UDI
FDA Product Code
LFL FDA UDI
GEI FDA UDI
KNS FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system holder/tip, single-use FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
878.4400 FDA UDI
876.4300 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

No

FDA UDI

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

SONICBEAT 5 mm, 10 cm, Inline Grip by Olympus Medical Systems Corporation — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K211838 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI c5adbc6d-446a-4a62-9c15-cf3639c4c02f 34 fields · synced May 30, 2026