Catalog Number

7498

Brand Name

LAM Fixation Standard

Version/Model Number

FIx_LAM_S_7498

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051085

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

f224b75a-3f9d-4b79-96f1-3f43b567bf85

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-