Catalog Number

72205109

Brand Name

NA

Version/Model Number

72205109

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

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Public Device Record Key

f88b49fb-456b-492b-ac61-4b617f76c0f0

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

January 07, 2019

Package DI Number

20885556708907

Quantity per Package

6

Contains DI Package

00885556708903

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX