FDA.reportPublic FDA data

Intimate Rose

Primary DI
00850005838487
Brand
Intimate Rose
Company
PLUS EV HOLDINGS INC.
Model
IR-035-1
Device description
Intimate Rose Rectal Dilator Size 1
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005838487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005838487008500058384878500058384870850005838487

GMDN Terms#

Term, Definition table
TermDefinition
Rectal dilator, reusableA surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
888-534-7673support@intimaterose.com

Regulatory Flags#

DUNS number
054962595
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005838135Intimate RoseIR-0022020-10-29
00850005838029Intimate RoseIR-0142024-12-10
00850005838036Intimate RoseIR-0152024-12-10
00850005838043Intimate RoseIR-0162024-12-10
00850005838050Intimate RoseIR-017-12024-12-10
00850005838067Intimate RoseIR-017-22024-12-10
00850005838074Intimate RoseIR-017-32024-12-10
00850005838081Intimate RoseIR-017-42024-12-10
00850005838098Intimate RoseIR-017-52024-12-10
00850005838104Intimate RoseIR-017-62024-12-10
00850005838111Intimate RoseIR-017-72024-12-10
00850005838128Intimate RoseIR-017-82024-12-10
00850005838142Intimate RoseIR-0222024-12-10
00850005838159Intimate RoseIR-0212024-12-10
00850005838395Intimate RoseIR-0252024-12-10
00850005838432Intimate RoseIR-0342024-12-10
00850005838449Intimate RoseIR-0302024-12-10
00850005838456Intimate RoseIR-0312024-12-10
00850005838463Intimate RoseIR-0322024-12-10
00850005838494Intimate RoseIR-035-22024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005838449Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838456Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838463Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838494Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
G586UR6213360Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
00842331194603Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216100Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216160Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217150Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217210Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217220Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217230Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217240Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
08033638801147DilastomSAPI MED SPAFFP2023-08-02
08033638803929DilastomSAPI MED SPAFFP2023-08-02
08033638800355Dilatan PlusSAPI MED SPAFFP2023-07-27