Catalog Number

622600

Brand Name

Spectraline™ 10mL Syringe

Version/Model Number

00884450167564

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"

-

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

-

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

c5cb1fa3-d6a4-4fcf-8fd3-07714f759c24

Public Version Date

April 28, 2021

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

10884450167561

Quantity per Package

25

Contains DI Package

00884450167564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-