FLOWTUBE HF - 1299-00-24 - Pajunk GmbH Medizintechnologie

Duns Number:317654283

Device Description: 1299-00-24

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More Product Details

Catalog Number

1299-00-24

Brand Name

FLOWTUBE HF

Version/Model Number

1299-00-24

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

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

0b438235-24a7-4a73-ba90-60977c2095aa

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

April 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAJUNK GMBH MEDIZINTECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 979