Catalog Number

5338-70

Brand Name

TRANSLATING ARM BOARD ASSY, FOR 5338

Version/Model Number

5338-70

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

-

Product Code

JEA

Product Code Name

Table, Surgical With Orthopedic Accessories, Ac-Powered

Public Device Record Key

0304d8df-8f17-4c47-8825-246223d568d8

Public Version Date

January 22, 2021

Public Version Number

1

DI Record Publish Date

January 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-