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Sonicweld Rx

FDA UDI

Class II (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
SONICWELD RX FDA UDI
Generic Name
Bone pin ultrasonic osteosynthesis system FDA UDI
Device Name
ULTRASONIC UNIT FDA UDI
Model / Reference
52-500-01-04 FDA UDI
Description
ULTRASONIC UNIT FDA UDI

Identifiers

Primary DI / UDI-DI
00888118084859 FDA UDI
FDA Product Code
JEY FDA UDI
GMDN Term
Bone pin ultrasonic osteosynthesis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 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

Yes

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

Category: Bone pin ultrasonic osteosynthesis system

Sonicweld Rx by KLS-Martin L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone pin ultrasonic osteosynthesis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KLS-Martin L.P.

Sources (1)

  • FDA UDI ef82202d-dab2-4931-a970-49fd2cf4907c 34 fields · synced May 30, 2026