Catalog Number

-

Brand Name

Affirm, 14mm Tip

Version/Model Number

100-7004-814

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

-

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

K070063,K081424,K101601,K070063,K081424,K101601

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

730a4179-10ff-49b6-9da0-714d88f5d257

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10841494100510

Quantity per Package

3

Contains DI Package

00841494100513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-