Catalog Number

EAD-P4-010

Brand Name

External Remote Controller

Version/Model Number

ERC 4P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K191336

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

7c20102e-fe1b-4de7-b0e2-758fc781aee5

Public Version Date

October 21, 2021

Public Version Number

6

DI Record Publish Date

October 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-