Catalog Number

108-1416

Brand Name

Epimed

Version/Model Number

108-1416

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

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

K053318,K053318

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

3d7854db-5268-457a-b66b-04bed6608570

Public Version Date

November 06, 2020

Public Version Number

1

DI Record Publish Date

October 29, 2020

Package DI Number

10818788023503

Quantity per Package

10

Contains DI Package

00818788023506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case