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Styro-former, Basic SF319A

FDA UDI

Class I (US FDA UDI)

by Huestis Machine Corp.

Identity

Trade Name
Styro-former, Basic SF319A FDA UDI
Generic Name
Radiation therapy beam block production hot-wire FDA UDI
Device Name
Styro-former shielding block cutter cuts foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment, FDA UDI
Model / Reference
SF319A FDA UDI
Description
Styro-former shielding block cutter cuts foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment, FDA UDI

Identifiers

Primary DI / UDI-DI
00850077007170 FDA UDI
FDA Product Code
KPY FDA UDI
GMDN Term
Radiation therapy beam block production hot-wire FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation therapy beam block production hot-wire

Styro-former, Basic SF319A by Huestis Machine Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy beam block production hot-wire.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Huestis Machine Corp.

Sources (1)

  • FDA UDI 18ac3cc0-a757-40d5-bdc6-aed9d2386b21 33 fields · synced May 30, 2026