Clearsight Bolus

GUDID 10850020486042

Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 40cm x 40cm

CLEARSIGHT RT LLC

Radiation therapy bolus, single-use
Primary Device ID10850020486042
NIH Device Record Keyf6551e3e-d8e8-4241-aca4-a976a71bce8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearsight Bolus
Version Model NumberB-05-20-01
Company DUNS117523635
Company NameCLEARSIGHT RT LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width40 Centimeter
Length40 Centimeter
Width40 Centimeter
Length40 Centimeter
Width40 Centimeter
Length40 Centimeter
Width40 Centimeter
Length40 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store flat (not folded) in original packaging in a cool, dry environment.

Device Identifiers

Device Issuing AgencyDevice ID
GS110850020486042 [Primary]

FDA Product Code

IXGPhantom, Anthropomorphic, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

On-Brand Devices [Clearsight Bolus]

10850020486059Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 40cm x 40c
10850020486042Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 40cm x 40c
10850020486035Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 40cm x 40c
10850020486028Clearsight Bolus, 1.0cm water equivalent thickness, 1.15cm physical thickness, Clear, 30cm x 30c
10850020486011Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 30cm x 30c
00850020486007Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 30cm x 30c

Trademark Results [Clearsight Bolus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARSIGHT BOLUS
CLEARSIGHT BOLUS
88630363 not registered Live/Pending
Clearsight RT LLC
2019-09-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.