Catalog Number

171-2124

Brand Name

Epimed

Version/Model Number

171-2124

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

K981329,K981329

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

bc30b2a6-63bf-4565-a0ee-2b3149f4b84c

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 24, 2017

Package DI Number

10818788021295

Quantity per Package

10

Contains DI Package

00818788021298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case