Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

RM2025A_0005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

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

K854816,K854816

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

200d3b48-6269-4088-88a9-1c25f8f84212

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

20809160004729

Quantity per Package

10

Contains DI Package

10809160004722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-