INTRABEAM Spherical Sizer Set

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name: INTRABEAM Spherical Sizer Set FDA UDI
Generic Name: Intraoperative/postoperative therapeutic x-ray system applicator sizer FDA UDI
Device Name: The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device. FDA UDI
Model / Reference: 309121-9100-000 FDA UDI
Description: The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device. FDA UDI

Identifiers

Primary DI / UDI-DI: 04049539105509 FDA UDI
510(k) Number: K241174 FDA UDI
FDA Product Code: JAD FDA UDI
GMDN Term: Intraoperative/postoperative therapeutic x-ray system applicator sizer 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

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoperative/postoperative therapeutic x-ray system applicator sizer

INTRABEAM Spherical Sizer Set by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K241174 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: Carl Zeiss Meditec AG

Sources (1)

FDA UDI b91c9230-96b8-4c26-83b5-adcbcf7cfd5f 34 fields · synced Jun 8, 2026