Dr. Joel Kaplan's Metal Hand Pump System - Universal Size

GUDID 00850005747611

Dr. Joel Kaplan, Inc.

Penile vacuum device
Primary Device ID00850005747611
NIH Device Record Key0ad7b7ee-cf0d-4168-9dc4-87b739329f7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr. Joel Kaplan's Metal Hand Pump System - Universal Size
Version Model Number0302-W250-UNI
Company DUNS003934314
Company NameDr. Joel Kaplan, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005747611 [Primary]

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-06
Device Publish Date2023-08-29