Primary Device ID | 10850020486028 |
NIH Device Record Key | 0e1443df-b202-4313-9d8d-26fbbd0ebe95 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Clearsight Bolus |
Version Model Number | B-11-18-01 |
Company DUNS | 117523635 |
Company Name | CLEARSIGHT RT LLC |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Length | 30 Centimeter |
Width | 30 Centimeter |
Length | 30 Centimeter |
Width | 30 Centimeter |
Length | 30 Centimeter |
Width | 30 Centimeter |
Length | 30 Centimeter |
Width | 30 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment. |
Special Storage Condition, Specify | Between 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment. |
Special Storage Condition, Specify | Between 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment. |
Special Storage Condition, Specify | Between 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10850020486028 [Primary] |
IYP | Phantom, Anthropomorphic, Nuclear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-23 |
Device Publish Date | 2022-05-13 |
10850020486059 | Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 40cm x 40c |
10850020486042 | Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 40cm x 40c |
10850020486035 | Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 40cm x 40c |
10850020486028 | Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 30cm x 30c |
10850020486011 | Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 30cm x 30c |
00850020486007 | Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 30cm x 30c |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARSIGHT BOLUS 88630363 not registered Live/Pending |
Clearsight RT LLC 2019-09-25 |