Bolus

FDA UDI

Class I (US FDA UDI)

by Medtec LLC

Identity

Trade Name: Bolus FDA UDI
Generic Name: Radiation therapy bolus, reusable FDA UDI
Device Name: 40 x 40 x 0.5cm FDA UDI
Model / Reference: MTCB404005S FDA UDI
Description: 40 x 40 x 0.5cm FDA UDI

Identifiers

Catalog Number: MTCB404005S FDA UDI
Primary DI / UDI-DI: 00841439103951 FDA UDI
FDA Product Code: IXG FDA UDI
GMDN Term: Radiation therapy bolus, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 40 Centimeter FDA UDI
Width — 40 Centimeter FDA UDI

Category: Radiation therapy bolus, reusable

Bolus by Medtec LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Medtec LLC

Sources (1)

FDA UDI a649bc03-d43b-4c87-8a0c-883d8e0ca618 37 fields · synced Jun 1, 2026