debritom+ - debritom+ handpiece standard jet - Medaxis AG

Duns Number:480870674

Device Description: debritom+ handpiece standard jet

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More Product Details

Catalog Number

-

Brand Name

debritom+

Version/Model Number

2000.0003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2021

Issuing Agency

In HIBCC

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

FQH

Product Code Name

Lavage, Jet

Device Record Status

Public Device Record Key

f5009345-034e-468d-a098-b21ee378a366

Public Version Date

March 31, 2021

Public Version Number

4

DI Record Publish Date

April 02, 2019

Additional Identifiers

Package DI Number

B724200000031

Quantity per Package

5

Contains DI Package

B724200000030

Package Discontinue Date

March 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"MEDAXIS AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13