Action®

FDA UDI

Class II (US FDA UDI)

by Action Products, Inc.

Identity

Trade Name: Action® FDA UDI
Generic Name: Radiation therapy bolus, reusable FDA UDI
Model / Reference: Bolx II FDA UDI

Identifiers

Catalog Number: 32054040 FDA UDI
Primary DI / UDI-DI: 00089904008398 FDA UDI
510(k) Number: K811528 FDA UDI
FDA Product Code: JAD FDA UDI
GMDN Term: Radiation therapy bolus, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5900 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiation therapy bolus, reusable

Action® by Action Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy bolus, reusable.

Bolus — Medtec LLC · Class I
Bolus - Gel (film) — CDR Systems Inc · Class II
Bolus — Medtec LLC · Class I
Action® — Action Products, Inc. · Class II
Action® — Action Products, Inc. · Class II
Action® — Action Products, Inc. · Class II
Action® — Action Products, Inc. · Class II
Action® — Action Products, Inc. · Class II

Cleared under the same submission

K811528 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Action Products, Inc.

Sources (1)

FDA UDI 7eb5a2e6-53f1-4db8-a82b-0b24ef37702d 35 fields · synced Jun 9, 2026