Catalog Number

159-2112

Brand Name

Epimed

Version/Model Number

159-2112

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

K023140,K023140

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

0722c5b5-15fd-47f3-a1ff-eefeb12baf6b

Public Version Date

February 24, 2021

Public Version Number

1

DI Record Publish Date

February 16, 2021

Package DI Number

10818788023558

Quantity per Package

10

Contains DI Package

00818788023551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case