Clearsight Bolus

GUDID 10850020486035

Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 40cm x 40cm, (3) units per package

CLEARSIGHT RT LLC

Radiation therapy bolus, single-use Radiation therapy bolus, single-use Radiation therapy bolus, single-use Radiation therapy bolus, single-use

• Primary Device ID: 10850020486035
• NIH Device Record Key: e7958a9a-fa3f-4e80-bfe4-e4e272090ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearsight Bolus
• Version Model Number: B-03-20-01
• Company DUNS: 117523635
• Company Name: CLEARSIGHT RT LLC
• Device Count: 3
• 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

Device Dimensions

• Width: 40 Centimeter
• Length: 40 Centimeter
• Width: 40 Centimeter
• Length: 40 Centimeter
• Width: 40 Centimeter
• Length: 40 Centimeter
• Width: 40 Centimeter
• Length: 40 Centimeter

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850020486038 [Unit of Use]
GS1	10850020486035 [Primary]

FDA Product Code

• IYP: Phantom, Anthropomorphic, Nuclear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-23
• Device Publish Date: 2022-05-13

On-Brand Devices [Clearsight Bolus]

• 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