VACUETTE - Urine Set VACUETTE® Urine Tube + Urine Transfer - Greiner Bio-One GmbH

Duns Number:303639066

Device Description: Urine Set VACUETTE® Urine Tube + Urine Transfer Device (455028+450751), single- packed, Co Urine Set VACUETTE® Urine Tube + Urine Transfer Device (455028+450751), single- packed, Conical Base, 9 ml, 16x100

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More Product Details

Catalog Number

453070

Brand Name

VACUETTE

Version/Model Number

453070

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

-

Product Code Details

Product Code

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Device Record Status

Public Device Record Key

fed9f376-8801-400e-89c5-f2bc8ad8d211

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

29120017578042

Quantity per Package

300

Contains DI Package

19120017578045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GREINER BIO-ONE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 21