Impoaid 44023-001

GUDID 00850358007097

Ring Kit

ENCORE, INC.

Penile rigidity splint
Primary Device ID00850358007097
NIH Device Record Key2cc8f6d1-d9ff-4de2-b942-93fe67c1b40c
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpoaid
Version Model NumberRing Kit
Catalog Number44023-001
Company DUNS614647725
Company NameENCORE, 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-Countertrue

Customer Support Contacts

Phone800-475-3091
Emailinfo@revivepremium.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850358007097 [Primary]

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [Impoaid]

00850358007097Ring Kit
00850358007073Battery Vacuum Erection Device
00850358007004VTU-1

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