AccessGUDID - DEVICE: RigiScan Plus (00854759007007)

GUDID

Device Identifier (DI) Information

Brand Name: RigiScan Plus
Version or Model: 9001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9001
Company Name: GOTOP MEDICAL INC

Primary DI Number: 00854759007007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045738761 *Terms of Use

Device Description: RigiScan Plus System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33890	Penile tumescence ambulatory recorder	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIL	Monitor, Penile Tumescence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941781	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8ed8e32-b4af-4661-b491-9ed85055da76
Public Version Date: November 07, 2022
Public Version Number: 4
DI Record Publish Date: November 01, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 651-283-5125
Email: Claire.Hovland@gotopmedical.com

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