Catalog Number

SYR193272

Brand Name

Medline

Version/Model Number

SYR193272

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

K150758,K150758,K150758,K150758

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

53a2605a-efef-44cf-ab80-8a3c638a7b24

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Package DI Number

00888277726652

Quantity per Package

10

Contains DI Package

10888277726659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG