← Back to catalogue

Ls3-14b

FDA UDI

Class II (US FDA UDI)

by Samsung Medison Co., Ltd

Identity

Trade Name
LS3-14B FDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Model / Reference
USP-L03ENNA/WR FDA UDI

Identifiers

Primary DI / UDI-DI
08806167798147 FDA UDI
510(k) Number
K182894 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution
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

Category: Extracorporeal ultrasound imaging transducer, hand-held

Ls3-14b by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Cleared under the same submission

K182894 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
Samsung Medison Co., Ltd

Sources (1)

  • FDA UDI 08520159-3057-410f-8052-acc24c147802 33 fields · synced May 30, 2026