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.decimal Photon Block

FDA UDI

Class II (US FDA UDI)

by .Decimal, LLC

Identity

Trade Name
.decimal Photon Block FDA UDI
Generic Name
Radiation therapy beam block material FDA UDI
Device Name
A custom manufactured Photon Beam Shaping Block for external beam radiation therapy. FDA UDI
Model / Reference
1.3 FDA UDI
Description
A custom manufactured Photon Beam Shaping Block for external beam radiation therapy. FDA UDI

Identifiers

Primary DI / UDI-DI
00851147007045 FDA UDI
510(k) Number
K123015 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 Photon Block 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 b07de792-6527-4017-805a-cca5e75c2113 35 fields · synced May 30, 2026