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Clearsight Bolus

FDA UDI

Class I (US FDA UDI)

by Clearsight Rt Llc

Identity

Trade Name
Clearsight Bolus FDA UDI
Generic Name
Radiation therapy bolus, single-use FDA UDI
Device Name
Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 30cm x 30cm FDA UDI
Model / Reference
B-05-18-01 FDA UDI
Description
Clearsight Bolus, 0.5cm water equivalent thickness, 0.57cm physical thickness, Clear, 30cm x 30cm FDA UDI

Identifiers

Primary DI / UDI-DI
10850020486011 FDA UDI
FDA Product Code
IXG FDA UDI
IYP FDA UDI
GMDN Term
Radiation therapy bolus, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1950 FDA UDI
892.1370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 30 Centimeter FDA UDI
Width — 30 Centimeter FDA UDI

Category: Radiation therapy bolus, single-use

Clearsight Bolus by Clearsight Rt Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy bolus, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clearsight Rt Llc

Sources (1)

  • FDA UDI e0d591e9-e121-400f-8bf5-869fcbb893a9 35 fields · synced Jun 8, 2026