Catalog Number

105-1313

Brand Name

Epimed

Version/Model Number

105-1313

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

429e6a0b-90dc-43d5-9760-d7bfa82c291e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2017

Package DI Number

10818788020069

Quantity per Package

10

Contains DI Package

00818788020062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case