FDA.reportPublic FDA data

PLUS EV HOLDINGS INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116304653011630465PLUS EV HOLDINGS INC1Y2026-01-011419 Murray St North Kansas City MO US 64116

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005838029Intimate Rose - Intimate Rose Small 4Pack Dilators (1-4)888-534-7673support@intimaterose.com
00850005838036Intimate Rose - Intimate Rose Medium 4Pack Dilators (3-6)888-534-7673support@intimaterose.com
00850005838043Intimate Rose - Intimate Rose Large 4Pack Dilators (5-8)888-534-7673support@intimaterose.com
00850005838050Intimate Rose - Intimate Rose Size 1 Vaginal Dilator888-534-7673support@intimaterose.com
00850005838067Intimate Rose - Intimate Rose Size 2 Vaginal Dilator888-534-7673support@intimaterose.com
00850005838074Intimate Rose - Intimate Rose Size 3 Vaginal Dilator888-534-7673support@intimaterose.com
00850005838135Intimate Rose - Intimate Rose Kegel Exercise System for pelvic floor weakness. Includes 6 silicone weights and instructions.888-534-7673support@intimaterose.com
00850005838159Intimate Rose - Intimate Rose Pelvic Wand - Vibrating - Green888-534-7673support@intimaterose.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1892001219740175K241748Intimate Rose Vaginal DilatorsHDX2024-08-14
1892001463879489K231430Intimate Rose Vaginal DilatorsHDX2023-06-07
1892001673848360K193364Intimate Rose Kegel Exercise SystemHIR2020-08-24
1892001598836122K160211Wet Original Personal LubricantNUC2016-04-27
1892001796494141
1892001892499197
1892001104162948
1892001115263685
1892001350171186
1892001426637418
1892001577206754
1892001905225414
1892002002726595
1892002003286387

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HDX22024-08-14
HIR12020-08-24
NUC12016-04-27

PMN#

GUDID#