Catalog Number

26046

Brand Name

Exel 1ml Tuberculin Zero Dead Space Syringe With Permanently Attached Needle

Version/Model Number

26046

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

K861153

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

b0b62b9e-ce4a-443f-990e-c4b54803a9dd

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-