Catalog Number

SHER010-12

Brand Name

AVID TruCustom

Version/Model Number

SHER010-12_0003

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

-

Product Code

OGJ

Product Code Name

Nerve block tray

Public Device Record Key

9f2e64d3-32f0-4671-b989-9374a168d668

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 05, 2018

Package DI Number

20809160211554

Quantity per Package

2

Contains DI Package

10809160211557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-