AccessGUDID - DEVICE: OLINDA/EXM (00859873006035)

GUDID

Device Identifier (DI) Information

Brand Name: OLINDA/EXM
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hermes Medical Solutions AB

Primary DI Number: 00859873006035
Issuing Agency: GS1
Commercial Distribution End Date: July 25, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 354140220 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40937	Nuclear medicine system workstation	A freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYX	Camera, Scintillation (Gamma)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f2c186c-a8d2-41df-a68e-6a9269eb745d
Public Version Date: July 06, 2023
Public Version Number: 5
DI Record Publish Date: August 21, 2017