Catalog Number

-

Brand Name

BULK, NON-STERILE UNIVERSAL SYRINGE TIP ADAPTER

Version/Model Number

18B-B

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K894217,K894217

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

845613e3-0d19-4e53-99b5-d1edd690d5bb

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Package DI Number

10810080610023

Quantity per Package

500

Contains DI Package

00810080610026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case