OLINDA/EXM

Basic Information

• Brand Name: OLINDA/EXM
• Primary DI: 00859873006035
• Version / Model: 2
• Company Name: Hermes Medical Solutions AB
• Labeler DUNS: 354140220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-21
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0f2c186c-a8d2-41df-a68e-6a9269eb745d
• Distribution End Date: 2027-07-25

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYX	Camera, Scintillation (Gamma)	Radiology	892.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859873006035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]