Catalog Number

-

Brand Name

Gemtier

Version/Model Number

SY012525

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

K192679,K192679,K192679

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

ca58d7ea-7cef-47f7-9aaa-a3f38eae5d1c

Public Version Date

March 30, 2021

Public Version Number

1

DI Record Publish Date

March 22, 2021

Package DI Number

16955356111478

Quantity per Package

100

Contains DI Package

06955356111471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER PACK