Catalog Number

-

Brand Name

INFLATION SYSTEM

Version/Model Number

03.804.413S

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

7fcf09f3-9b58-4289-aa48-092077cbe4d9

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

April 12, 2017

Package DI Number

13661234017437

Quantity per Package

1

Contains DI Package

03661234017430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-