Catalog Number

G900013

Brand Name

NA

Version/Model Number

G900013

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153446

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

81681efe-7db1-4a9e-b5d5-3008595af69d

Public Version Date

July 24, 2019

Public Version Number

1

DI Record Publish Date

July 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-