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.decimal Electron Aperture

FDA UDI

Class II (US FDA UDI)

by .Decimal, LLC

Identity

Trade Name
.decimal Electron Aperture FDA UDI
Generic Name
Radiation therapy beam block material FDA UDI
Device Name
A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue. FDA UDI
Model / Reference
1.0 FDA UDI
Description
A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue. FDA UDI

Identifiers

Primary DI / UDI-DI
00851147007038 FDA UDI
510(k) Number
K111759 FDA UDI
FDA Product Code
IXI FDA UDI
GMDN Term
Radiation therapy beam block material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5710 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiation therapy beam block material

.decimal Electron Aperture by .Decimal, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy beam block material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
.Decimal, LLC

Sources (1)

  • FDA UDI 0710ab37-066a-4980-a672-b396c72c7d2c 35 fields · synced Jun 1, 2026