FDA.reportPublic FDA data

Alatus

Primary DI
00851546007004
Brand
Alatus
Company
RADIADYNE, L.L.C.
Model
ALA-45 Unit Tray
Catalog number
ALA-45
Device description
Alatus Vaginal Balloon Packing System Kit
Published
2016-09-12
Public version status
Update
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
10851546007001PackageGS15In Commercial Distribution
20851546007008PackageGS15In Commercial Distribution
00851546007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154600700110851546007001
2085154600700820851546007008
00851546007004008515460070048515460070040851546007004

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-759-9600leahroe@radiadyne.com

Regulatory Flags#

DUNS number
005744772
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851546007011ImmobiLocIL-60IL-602016-09-12
00851546007028ImmobiLocIL-100IL-1002016-09-12
00851546007035ImmobiLocILG-60FILG-60F2016-09-12
00851546007042ImmobiLocILG-60F-60mlILG-60F060ml2016-09-12
00851546007059ImmobiLocILG-90FILG-90F2016-09-12
00851546007066OARtracORB-60FORB-60F2016-09-22
00851546007073OARtracOT1-PSD-2UOT1-PSD-2U2016-09-23
00851546007103IsoLocISO-100ISO-1002018-01-31
00851546007141Photon MicroPSDPSD-PE5NPSD-PE5N2018-03-23
00851546007165QC microPSDPSD-QC5NPSD-QC5N2019-06-06
00851546007219IsoLocISO-60ISO-602018-01-31
00851546007417Photon microPSDPSD-PE5NPSD-PE5N2018-05-08
00851546007516QC microPSDPSD-QE5NPSD-QE5N2018-05-08
00851546007615Electron microPSDPSD-EE5NPSD-EE5N2019-05-22
20851546007091IsoLocISO-60ISO-602018-01-31
00851546007196OARtrac OT-CDU2POT-CDU2P2019-07-03
00851546007080OARtracOT-CDUOT-CDU2016-09-23
00851546007097OARtracOT-PSSOT-PSS2016-09-23
00851546007158QC MicroPSDPSD-QE5NPSD-QE5N2018-03-23
00851546007714HDR microPSDPSD-HB5NPSD-HB5N2018-05-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937304eMotusEMPNIA INC.IYE2026-09-21