Catalog Number

-

Brand Name

LDR Spine USA

Version/Model Number

0022LDR

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)

-

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

7055814e-e3e7-4dbd-9d30-abd402c2e969

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 09, 2018

Package DI Number

10843059121794

Quantity per Package

2

Contains DI Package

00843059121797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Subpack