Catalog Number

LT280T

Brand Name

AESCULAP

Version/Model Number

LT280T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 08, 2016

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

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

3e4111d4-51e6-44bf-ac40-f52426771d8c

Public Version Date

June 27, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-