Catalog Number

5450-800-207

Brand Name

Spetzler, Claw

Version/Model Number

5450800207

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 2021

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

01a7966c-9d34-414a-8746-509aa3c61458

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

37613252026526

Quantity per Package

5

Contains DI Package

07613252026525

Package Discontinue Date

August 02, 2021

Package Status

Not in Commercial Distribution

Package Type

pack