FDA.reportPublic FDA data

Alatus

Primary DI
H787VBP400
Brand
Alatus
Company
ANGIODYNAMICS, INC.
Model
VBP-40
Device description
Alatus Vaginal Balloon Packing System
Published
2024-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092534000ALATUS VAGINAL BALLOON PACKING SYSTEMRadiadyne2009-12-07JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787VBP400PrimaryHIBCC0
15051684018913SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401891315051684018913

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy lesion localization urethral catheter, planningA flexible tube with a non-powered radiopaque marker (e.g., barium) at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocentre of a radiation therapy system during treatment planning. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
15051684023856Uni-Fuse+H787124018520124018522024-08-01
15051684023863Uni-Fuse+H787124018540124018542024-08-01
15051684023870Uni-Fuse+H787124018550124018552024-08-01
15051684023887Uni-Fuse+H787124018570124018572024-08-01
15051684023894Uni-Fuse+H787124018580124018582024-08-01
15051684023900Uni-Fuse+H787124018590124018592024-08-01
15051684023924Uni-Fuse+H787124018610124018612024-08-01
15051684023931Uni-Fuse+H787124018620124018622024-08-01
15051684023948Uni-Fuse+H787124018630124018632024-08-01
15051684030069NanoKnifeH78720300351US020300351US2026-05-04
15051684013727NanoKnifeH78720300301US020300301US2026-04-30
15051684017930NanoKnifeH787204001090204001092026-04-30
15051684017947NanoKnifeH787204001100204001102026-04-30
15051684017954NanoKnifeH787204003010204003012026-04-30
15051684029643NanoKnifeH787204001110204001112026-04-30
H787204001110NanoKnife204001112022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWL9814740BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWL9814750BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWL9814760BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWL9814770BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWL9814780BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWL9814790BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWT930010BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWT930020BEAMSCANPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTM100520UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTM100530UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTN100520UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTN100530UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTW100520UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
EPTWTW100530UNIDOSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-14
08058045280125TOTIM Patient Cushion Immobilization SystemESSEBI MEDICAL SRLIYE2020-03-06
08058045280170TOTIM Patient Cushion Immobilization SystemESSEBI MEDICAL SRLIYE2020-03-06
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11