Primary Device ID | 10628341930304 |
NIH Device Record Key | 55125cb6-ec26-4e19-9ecb-b08cb55025cb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Koilia Mikros |
Version Model Number | 1 |
Catalog Number | BB09-D |
Company DUNS | 206950904 |
Company Name | CDR Systems Inc |
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 | false |
OTC Over-The-Counter | false |
Phone | 403-850-7035 |
info@cdrsys.ca |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628341930307 [Primary] |
GS1 | 10628341930304 [Package] Contains: 00628341930307 Package: [1 Units] In Commercial Distribution |
IYE | Accelerator, Linear, Medical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-08 |
Device Publish Date | 2019-12-31 |
10628341930502 - EQUILIBRIUM | 2024-02-02 EQUILIBRIUM Rotating Overlay System |
10628341930373 - Thermoplastic | 2024-01-08 Thermoplastic Immobilization Materials |
10628341930380 - Thermoplastic | 2024-01-08 Thermoplastic Immobilization Mask |
10628341930465 - TBI | 2023-03-16 TBI Positioning System With Spoiler |
10628341930441 - Freedom | 2023-03-03 Freedom S-Type Overlay |
10628341930458 - Freedom | 2023-03-03 Freedom S-Type Overlay (MR Safe) |
00628341930406 - Solid Bolus | 2020-05-25 Solid Bolus |
10628341930427 - Freedom | 2020-05-25 Freedom Prone Head & Neck Immobilization (MR Conditional) |