FDA.reportPublic FDA data

Prostate Caddy Rectal Balloon

Primary DI
10860005263117
Brand
Prostate Caddy Rectal Balloon
Company
Myriad Medical, LLC
Model
3309
Catalog number
3309
Device description
Prostate Immobilization device. Rectal Balloon and inflation syringe, single use, non-sterile. Kit Box of 25.
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PCTProstate Immobilizer Rectal Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCTProstate Immobilizer Rectal BalloonRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860005263117PrimaryGS10
00860005263110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000526311710860005263117
00860005263110008600052631108600052631100860005263110

GMDN Terms#

Term, Definition table
TermDefinition
Rectal probeA hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical procedure. This is a reusable device.

Regulatory Flags#

DUNS number
842448610
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860005263100Prostate Caddy Rectal Balloon330133012020-09-23
10860005263124Prostate Caddy Rectal Balloon990199012020-09-23
10860005263131Inflation Luer Lock Syringe 1001002020-09-23
00860005263103Prostate Caddy Rectal Balloon330133012020-09-23
00860005263110Prostate Caddy Rectal Balloon330933092020-09-23
00860005263127Prostate Caddy Rectal Balloon990199012020-09-23
00860005263134Inflation Luer Lock Syringe 1001002020-09-23

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
08719326258218QLRADQLRAD INTERNATIONAL LTDPCT2020-09-28
10860005263100Prostate 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