myQA®Daily - myQA Daily Device - IBA Dosimetry GmbH

Duns Number:332599307

Device Description: myQA Daily Device

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More Product Details

Catalog Number

-

Brand Name

myQA®Daily

Version/Model Number

E3063100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

LHO

Product Code Name

Instrument, Quality-Assurance, Radiologic

Device Record Status

Public Device Record Key

119e295d-334d-403b-b01c-9dee6ecd64fa

Public Version Date

May 03, 2019

Public Version Number

1

DI Record Publish Date

April 25, 2019

Additional Identifiers

Package DI Number

EIBAE30631001

Quantity per Package

1

Contains DI Package

EIBAE30631000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carry Case

"IBA DOSIMETRY GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89
2 A medical device with a moderate to high risk that requires special controls. 177