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Aquaplast RT™

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
Aquaplast RT™ FDA UDI
Generic Name
Radiation therapy bolus, single-use FDA UDI
Device Name
Aquaplast RT Custom Bolus, 4.8mm, 7cm x 22cm FDA UDI
Model / Reference
RT-1908-4 FDA UDI
Description
Aquaplast RT Custom Bolus, 4.8mm, 7cm x 22cm FDA UDI

Identifiers

Catalog Number
RT-1908-4 FDA UDI
Primary DI / UDI-DI
10841962104101 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Radiation therapy bolus, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Width — 22 Centimeter FDA UDI
Depth — 4.8 Millimeter FDA UDI
Length — 7 Centimeter FDA UDI

Category: Radiation therapy bolus, single-use

Aquaplast RT™ by Qfix — Class II — 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
Qfix

Sources (1)

  • FDA UDI 5d84daa5-7fd9-4075-8c7d-d4686d67bca8 36 fields · synced May 30, 2026