Catalog Number

N-TW2730

Brand Name

SHARD

Version/Model Number

N-TW2730

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072739,K072739

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

dc642b34-66bd-499f-b51b-06ab25862a36

Public Version Date

June 08, 2022

Public Version Number

1

DI Record Publish Date

May 31, 2022

Package DI Number

10814639025474

Quantity per Package

100

Contains DI Package

00814639025477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box