Catalog Number

-

Brand Name

1cc TB LL Syringe

Version/Model Number

042220763000

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

K083686,K083686,K083686

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

f571b88c-5d33-4412-97f1-3e5cd8846947

Public Version Date

May 03, 2021

Public Version Number

2

DI Record Publish Date

January 01, 2019

Package DI Number

20853620005450

Quantity per Package

36

Contains DI Package

10853620005453

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-