RigiScan - Waist/Leg Strap Extender - GOTOP MEDICAL INC

Duns Number:045738761

Device Description: Waist/Leg Strap Extender

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More Product Details

Catalog Number

9029

Brand Name

RigiScan

Version/Model Number

9029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LIL

Product Code Name

Monitor, Penile Tumescence

Device Record Status

Public Device Record Key

2cd4fdff-e146-4390-8f8f-ef21e99fa74b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GOTOP MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 13