OLINDA/EXM - The intended use of OLINDA/EXM is to provide - Hermes Medical Solutions AB

Duns Number:354140220

Device Description: The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiati The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

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More Product Details

Catalog Number

-

Brand Name

OLINDA/EXM

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 25, 2027

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

K163687

Product Code Details

Product Code

IYX

Product Code Name

Camera, Scintillation (Gamma)

Device Record Status

Public Device Record Key

0f2c186c-a8d2-41df-a68e-6a9269eb745d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HERMES MEDICAL SOLUTIONS AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 9