QLRAD

Primary DI
08719326258218
Brand
QLRAD
Company
QLRAD INTERNATIONAL LTD
Model
105.1014
Device description
RectalPro75
Published
2020-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08719326258218PackageGS1100In Commercial Distribution
08719326258225PackageGS150In Commercial Distribution
08719326258232PackageGS1100In Commercial Distribution
08719326258249PackageGS12In Commercial Distribution
08719326258201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719326258218087193262582188719326258218
08719326258225087193262582258719326258225
08719326258232087193262582328719326258232
08719326258249087193262582498719326258249
08719326258201087193262582018719326258201

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
534509598
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720892233028QLRAD105.30002024-04-01
08720892233004QLRAD105.20002024-04-01
08720892233035QLRAD105.30002024-04-01
08719326258263QLRAD105.10182021-09-14
08719326258256QLRAD105.10012021-09-14
08719326258287QLRAD105.10182021-09-14
08719326258201QLRAD105.10142020-09-28

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
08719326258263QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258256QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258287QLRADQLRAD INTERNATIONAL LTDPCT2021-09-14
08719326258201QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
10860005263100Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
10860005263117Prostate Caddy Rectal BalloonMyriad Medical, LLCPCT2020-09-23
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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