QLRAD

Primary DI
08719326258263
Brand
QLRAD
Company
QLRAD INTERNATIONAL LTD
Model
105.1018
Device description
RectalPro75, switch valve LL with 100 cc Syringe
Published
2021-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PCTProstate immobilizer rectal balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCTProstate Immobilizer Rectal BalloonRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180478000RectalPro 75 Endorectal BalloonQlrad International , Ltd.2018-11-13PCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719326258287PackageGS150In Commercial Distribution
08719326258294PackageGS12In Commercial Distribution
08719326258263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326258287087193262582878719326258287
08719326258294087193262582948719326258294
08719326258263087193262582638719326258263

GMDN Terms#

Term, Definition table
TermDefinition
Prostate immobilization balloon catheterA non-sterile flexible tube with an inflatable balloon at its distal end intended to be inserted into the rectum to facilitate adequate positioning and immobilization of the prostate during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+13054378550awinkel@qlrad.com

Regulatory Flags#

DUNS number
534509598
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720892233028QLRAD105.30002024-04-01
08720892233004QLRAD105.20002024-04-01
08720892233035QLRAD105.30002024-04-01
08719326258256QLRAD105.10012021-09-14
08719326258287QLRAD105.10182021-09-14
08719326258201QLRAD105.10142020-09-28
08719326258218QLRAD105.10142020-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08715669008770Push bracesNea International B.V.PCT2022-12-02
08715669008787Push bracesNea International B.V.PCT2022-12-02
08715669008794Push bracesNea International B.V.PCT2022-12-02
08715669008800Push bracesNea International B.V.PCT2022-12-02
08715669008817Push bracesNea International B.V.PCT2022-12-02
08715669002976Push bracesNea International B.V.PCT2022-11-04
08715669002983Push bracesNea International B.V.PCT2022-11-04
08715669002990Push bracesNea International B.V.PCT2022-11-04
08715669003003Push bracesNea International B.V.PCT2022-11-04
08715669003010Push bracesNea International B.V.PCT2022-11-04
08715669003027Push bracesNea International B.V.PCT2022-11-04
08715669003034Push bracesNea International B.V.PCT2022-11-04
08715669008893Push Sports bracesNea International B.V.PCT2022-10-18
08715669002969Push bracesNea International B.V.PCT2022-10-11
08719326258256QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258287QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258201QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
08719326258218QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
10860005263100Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
10860005263117Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
10860005263124Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263103Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263110Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00860005263127Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
00851546007103IsoLocRADIADYNE, L.L.C.PCT2018-01-31
00851546007219IsoLocRADIADYNE, L.L.C.PCT2018-01-31
20851546007091IsoLocRADIADYNE, L.L.C.PCT2018-01-31
00851546007092IsoLocRADIADYNE, L.L.C.PCT2018-01-31
20851546007107IsoLocRADIADYNE, L.L.C.PCT2018-01-31
20851546007213IsoLocRADIADYNE, L.L.C.PCT2018-01-31