ERBE - ERBELIFT® Hand Pump - Erbe Elektromedizin GmbH

Duns Number:316116623

Device Description: ERBELIFT® Hand Pump

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


More Product Details

Catalog Number

-

Brand Name

ERBE

Version/Model Number

20350-000

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)

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

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Device Record Status

Public Device Record Key

5cd17fbb-8149-42b2-8335-be31b61cc563

Public Version Date

August 09, 2019

Public Version Number

3

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

-

"ERBE ELEKTROMEDIZIN GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 154