Catalog Number

-

Brand Name

Sterile Single-use Syringe with Needle

Version/Model Number

1mL LL 27G×1/2" (0.4mm×13mm)

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

K163161,K163161,K163161

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

745176b1-21e8-41be-9489-ed293a679a17

Public Version Date

February 02, 2021

Public Version Number

1

DI Record Publish Date

January 25, 2021

Package DI Number

16920756729844

Quantity per Package

100

Contains DI Package

06920756729847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-