Sprinter XL (model 160 samples, IFA incl. incubator) - EUROIMMUN Medizinische Labordiagnostika AG

Duns Number:322209263

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sprinter XL (model 160 samples, IFA incl. incubator)

Version/Model Number

YG 0033-0101-4

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

-

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 Details

Product Code

JQW

Product Code Name

Station, Pipetting And Diluting, For Clinical Use

Device Record Status

Public Device Record Key

81cc5be4-43e4-4c96-8419-75c6102f1056

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 115
2 A medical device with a moderate to high risk that requires special controls. 213