Catalog Number

126-1635

Brand Name

Epimed

Version/Model Number

126-1635

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

K030562,K030562

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

5a2a9f11-4575-4136-bb1c-2c70d3ba887c

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

10818788023275

Quantity per Package

25

Contains DI Package

00818788023278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case