FDA.reportPublic FDA data

INTRABEAM SMART Spherical Applicator (35mm)

Primary DI
04049539105554
Brand
INTRABEAM SMART Spherical Applicator (35mm)
Company
Carl Zeiss Meditec AG
Model
309120-9035-000
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JADSystem, Therapeutic, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JADSystem, Therapeutic, X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241174000INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AG2025-01-10JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049539105554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049539105554040495391055544049539105554

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-useA component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used in the treatment of certain clinical conditions (e.g., breast cancer). It has a ball-shaped distal end that is typically inserted into a resected tumour bed for the irradiation of the tumour bed and/or margins during an operation. It may be supplied as a set of graduated sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342228620
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14
04049539101594INTRABEAM® Spherical Applicator 3.0 cm304534-6000-5602017-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049539105509INTRABEAM Spherical Sizer SetCarl Zeiss Meditec AGJAD2025-06-20
04049539105516INTRABEAM SMART Spherical ApplicatorCarl Zeiss Meditec AGJAD2025-05-14
04049539105523INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105530INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539064080INTRABEAMCarl Zeiss Meditec AGJAD2025-04-01
04049539066503INTRABEAM SMART StandCarl Zeiss Meditec AGJAD2025-04-01
05060494200084X80 / RADiant / PhotoElectric Therapy SystemXSTRAHL LIMITEDJAD2024-05-08
08717213057760EsteyaNucletron B.V.JAD2022-08-16
00089904010728Action®ACTION PRODUCTS, INC.JAD2021-03-23
00628341930116Bolus - Gel (film)CDR Systems IncJAD2019-12-31
00628341930123Bolus - Gel (w/o Film)CDR Systems IncJAD2019-12-31
00850008977008Balloon ApplicatorIcad, Inc.JAD2019-11-05
00850008977015Balloon ApplicatorIcad, Inc.JAD2019-11-05
00858012005984Balloon ApplicatorIcad, Inc.JAD2019-11-05
00858012005991Balloon ApplicatorIcad, Inc.JAD2019-11-05
10850002237013SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237020SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237037SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
00089904008398Action®ACTION PRODUCTS, INC.JAD2018-07-06
08717213038820EsteyaNucletron B.V.JAD2018-06-12
08717213038837EsteyaNucletron B.V.JAD2018-06-12
08717213038844EsteyaNucletron B.V.JAD2018-06-12
00089904008077Action®ACTION PRODUCTS, INC.JAD2018-06-11
00089904007971Action®ACTION PRODUCTS, INC.JAD2018-04-06
00089904007964Action®ACTION PRODUCTS, INC.JAD2018-03-12
00089904007810Action®ACTION PRODUCTS, INC.JAD2018-01-29
00089904010827Action®ACTION PRODUCTS, INC.JAD2018-01-29