AccessGUDID - DEVICE: RigiScan (00854759007038)

GUDID

Device Identifier (DI) Information

Brand Name: RigiScan
Version or Model: 9033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9033
Company Name: GOTOP MEDICAL INC

Primary DI Number: 00854759007038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045738761 *Terms of Use

Device Description: Tip Tension Guide

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?
17442	Penile tumescence long-term ambulatory recorder transducer	A 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.	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: 06697000-7fda-4dd2-b05e-5ba2d7cba7cb
Public Version Date: November 07, 2022
Public Version Number: 3
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: Yes
Serial Number: No
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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