Oncentra External Beam Oncentra Brachy v4.6.1 Medical Device Identification

GUDID 08717213052758

Radiation therapy software

Primary Device ID	08717213052758
NIH Device Record Key	b2b94d2d-e493-4b91-8f67-865b4abf8488
Commercial Distribution Status	In Commercial Distribution
Version Model Number	170607-00
Company DUNS	415269930
Company Name	Nucletron B.V.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08717213052758 [Primary]

MUJ	System, planning, radiation therapy treatment

Steralize Prior To Use	false
Device Is Sterile	false

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08717213057258 - Smit Sleeve	2024-07-15 Smit Sleeve CT/MR, 4mm
08717213054363 - Luneray	2022-11-23 Catheter 6F 50cm, needle 37mm R30mm
08717213054370 - Luneray	2022-11-23 Catheter 6F 50cm, needle 47mm R45mm
08717213054387 - Luneray	2022-11-23 Catheter 6F 50cm, needle 57mm R60mm
08717213054394 - Luneray	2022-11-15 Catheter 6F 50cm, needle 67mm R75mm
08717213057760 - Esteya	2022-08-24 Esteya