Primary Device ID | B9873X30 |
NIH Device Record Key | 2913bbc9-b13d-4b98-99c0-6c9b68311c94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Radiochromic.com |
Version Model Number | 3.3 |
Company DUNS | 468141103 |
Company Name | RADIOCHROMIC SL. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B9873X30 [Primary] |
MWW | Accessory - Film Dosimetry System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-29 |
Device Publish Date | 2020-10-21 |
B9873X30 | Radiochromic film dosimetry and radiation therapy QA software |
B9873X40 | Radiochromic film dosimetry and radiation therapy QA software |
B9874X00 | Radiochromic film dosimetry and radiation therapy QA software |
B9875X00 | Radiochromic film dosimetry and radiation therapy QA software |
B9875X10 | Radiochromic film dosimetry and radiation therapy QA software |