FDA.reportPublic FDA data

RigiScan

Primary DI
00854759007021
Brand
RigiScan
Company
GOTOP MEDICAL INC
Model
9021
Catalog number
9021
Device description
Base Tension Guide
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
00854759007021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854759007021008547590070218547590070210854759007021

GMDN Terms#

Term, Definition table
TermDefinition
Penile tumescence long-term ambulatory recorder transducerA device intended to be used together with a parent device (e.g., a penile tumescence long-term trend recorder) to detect the swelling of the penis and provide the electronic signals of the physiological changes which are processesed and displayed as measurements by the parent device. This is a reusable device.

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
00854759007038RigiScan903390332017-11-01
00854759007045RigiScan902090202017-11-01
00854759007052RigiScan61597615972017-11-01
00854759007069RigiScan903090302017-11-01
00854759007076RigiScan902990292017-11-01
00854759007083RigiScan606003-004606003-0042017-11-01
00854759007090RigiScan903490342017-11-01
00854759007106RigiScan902690262017-11-01

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
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
00854759007106RigiScanGOTOP MEDICAL INCLIL2017-11-01