Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

MHSH2202_0006

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

K884792,K884792

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

54093952-62b9-4c5c-901c-02a8953ee633

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

20809160055516

Quantity per Package

10

Contains DI Package

10809160055519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-