Home GUDID 00860001453805 RestoreX
Primary DI 00860001453805
Brand RestoreX
Company PathRight Medical Inc.
Model 117
Catalog number 117
Device description RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use
Published 2020-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name IQI Orthosis, Limb Brace
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IQI Orthosis, Limb Brace Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860001453805 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860001453805 00860001453805 860001453805 0860001453805
GMDN Terms# Term, Definition table Term Definition Penile traction splint A mechanical device worn on the penis typically for gradual penile lengthening or for the non-surgical correction of penile curvature (Peyronie's disease); it may be used after plastic surgery to the penis (phalloplasty). It operates on the principle of traction and typically consists of a base-ring that rests against the pubic bone, a penis head holder, and expandable rods that can exert a constant load between the root and the head of the penis; it may have elements to create an angular force. This is a reusable device.
Regulatory Flags# DUNS number 092965880 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00636257215913 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00636257215920 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00636257215937 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00636257215944 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00636257215951 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00636257215968 MEDI MEDI MANUFACTURING, INC. IQI 2026-08-21 00190446660590 PROCARE DJO, LLC IQI 2026-07-31 00190446660606 PROCARE DJO, LLC IQI 2026-07-31 00190446660613 PROCARE DJO, LLC IQI 2026-07-31 00190446660620 PROCARE DJO, LLC IQI 2026-07-31 00190446660637 PROCARE DJO, LLC IQI 2026-07-31 00190446660644 PROCARE DJO, LLC IQI 2026-07-31 00810178883127 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883134 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883141 Vive VIVE HEALTH LLC IQI 2026-07-21 00810178883158 Vive VIVE HEALTH LLC IQI 2026-07-21 00400000326986 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000326993 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327006 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327013 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327020 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327037 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327044 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327051 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327068 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327075 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327082 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327099 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327105 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20 00400000327112 MEDI MEDI MANUFACTURING, INC. IQI 2026-07-20
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