RigiScan

Primary DI
00854759007106
Brand
RigiScan
Company
GOTOP MEDICAL INC
Model
9026
Catalog number
9026
Device description
Event Marker Switch, RigiScan
Published
2017-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LILMonitor, Penile Tumescence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LILMonitor, Penile TumescenceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941781000RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMDacomed Corp.1994-08-25LIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854759007106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854759007106008547590071068547590071060854759007106

GMDN Terms#

Term, Definition table
TermDefinition
Penile tumescence ambulatory recorderAn electrically-powered device intended for 24-hour recording of the tumescence (tendency to swell) of the penis. The patient is connected to and wears the device while he performs normal daily activities and is used to register the plethysmographic measurement or function of the penile erection, e.g., length, circumference, duration of the erection. The measurements are made by, e.g., a plethysmographic sleeve or a transducer placed on the penis and the data is recorded by this device and later used by the physician for the diagnosis of penile dysfunction, e.g., impotence.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-283-5125Claire.Hovland@gotopmedical.com

Regulatory Flags#

DUNS number
045738761
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854759007042RigiScan909190912017-11-01
10854759007059RigiScan31665316652017-11-01
00854759007007RigiScan Plus900190012017-11-01
00854759007014RigiScan900390032017-11-01
00854759007021RigiScan902190212017-11-01
00854759007038RigiScan903390332017-11-01
00854759007045RigiScan902090202017-11-01
00854759007052RigiScan61597615972017-11-01
00854759007069RigiScan903090302017-11-01
00854759007076RigiScan902990292017-11-01
00854759007083RigiScan606003-004606003-0042017-11-01
00854759007090RigiScan903490342017-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00363736000158NixMedtech Products Inc.LIL2020-06-24
00363736109387NixMedtech Products Inc.LIL2020-06-24
00363736110062NixMedtech Products Inc.LIL2020-06-24
10854759007042RigiScanGOTOP MEDICAL INCLIL2017-11-01
10854759007059RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007007RigiScan PlusGOTOP MEDICAL INCLIL2017-11-01
00854759007014RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007021RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007038RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007045RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007052RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007069RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007076RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007083RigiScanGOTOP MEDICAL INCLIL2017-11-01
00854759007090RigiScanGOTOP MEDICAL INCLIL2017-11-01