FDA.reportPublic FDA data

Wellness

Primary DI
00819835023425
Brand
Wellness
Company
Blush Novelties
Model
Wellness - Dilator Kit - Purple
Catalog number
BL-444111
Device description
Wellness - Dilator Kit - PurplePart Number: BL-444111Material Type: Silicone
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HDQDilator, Cervical, Fixed Size

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819835023425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819835023425008198350234258198350234250819835023425

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal dilatorA firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057027601
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002870800BlushBlush Lube - Water-Based - 4 FL Oz.BL-100492025-09-26
00850002870718Performance PlusPerformance Plus - Flex Pro - BlueBL-900022025-03-17
00850002870725Performance PlusPerformance Plus - Dual Flex Pro - BlueBL-900122025-03-17
00810138370834DeliceDelice - Chéri - Kegel Trainer - PurpleBL-237212025-03-13
00850002870619Performance PlusPerformance Plus - Throttle - BlackBL-920052025-02-14
00850002870626Performance PlusPerformance Plus - Engage - Black / BlueBL-920022025-02-14
00850002870633Performance PlusPerformance Plus - Accelerate - BlackBL-920152025-02-14
00850002870640Performance PlusPerformance Plus - Pursuit - RedBL-920082025-02-14
00850002870657Performance PlusPerformance Plus - Traction - BlackBL-920252025-02-14
00850002870664Performance PlusPerformance Plus - Drift - BlackBL-920352025-02-14
00850002870671Performance PlusPerformance Plus - Flash - MultiBL-920222025-02-14
00850002870688Performance PlusPerformance Plus - Takeoff - Red/BlackBL-922222025-02-14
00850002870695Performance PlusPerformance Plus - Flare - Black / NeonckBL-923222025-02-14
00850002870701Performance PlusPerformance Plus - Launch - BlackBL-920452025-02-14
00819835024125WellnessWellness - Kegel Training Kit - PurpleBL-4440042025-01-28
00850002870565Play With MePlay With Me - Pleaser Rechargeable C-Ring - Neon BL-316222024-12-13
00850002870572Play With MePlay With Me - Pleaser Rechargeable C-Ring - PinkBL-316102024-12-13
00853858007383Stay HardStay Hard - Beaded Cock Rings - BlackBL-000152022-12-06
00853858007451Stay HardStay Hard - Donut Rings - 50 Piece Display EditBC-0082022-12-06
00853858007611Play With MePlay With Me - Stretch C-Ring - 50 piecesBC-0092022-12-06

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