Perfektum® - TB Match Num 1/2mL in 1/100mL, Glass Tip - CADENCE SCIENCE, INC.

Duns Number:001618818

Device Description: TB Match Num 1/2mL in 1/100mL, Glass Tip

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More Product Details

Catalog Number

5201

Brand Name

Perfektum®

Version/Model Number

5201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2019

Issuing Agency

In GS1

Product Characteristics

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

-

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

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

5189e410-f86d-412d-9f66-d61890033665

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CADENCE SCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 59