Catalog Number

5450-815-107

Brand Name

NA

Version/Model Number

5450815107

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

82965c46-6015-40a3-bc86-066e328bf1be

Public Version Date

October 25, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

37613252518380

Quantity per Package

5

Contains DI Package

07613252518389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack