Hope&Her Vaginal Dilators

Primary DI
00860012225002
Brand
Hope&Her Vaginal Dilators
Company
LUJENA, INC.
Model
T8077
Device description
Hope&Her Vaginal Dilators are indicated to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. The set includes 6 comfortable dilator sizes and an easy-to-attach universal handle. The dilators have a silky-smooth, seamless texture and are not made with BPA, Latex, or silicone. The patented, gentle-tapered design promotes an easy size transition from the smallest size up through the largest. The handle locks on easily and is very study to allow PT muscle manipulation.
Published
2024-11-15
Public version status
Update
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
HDXDilator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDXDilator, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233689000Hope&Her Vaginal DilatorsLujena, Inc.2024-05-02HDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012225002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012225002008600122250028600122250020860012225002

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6194491200care@vaginismus.com

Regulatory Flags#

DUNS number
080271509
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262494460791N/ADoppkon GmbH & Co. KGHDX2025-09-10
00810142352307Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-30
00810142352215Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352222Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352239Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352246Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352260Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352277Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352284Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352291Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-29
00810142352314Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-12
00810142352253Bioteque America, Inc.Bioteque America, Inc.HDX2025-05-08
00850005838029Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838036Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838043Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838050Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838067Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838074Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838081Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838098Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838104Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838111Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
00850005838128Intimate RosePLUS EV HOLDINGS INC.HDX2024-12-10
B8034701660ORTHOMEDORTHO-MED, INC.HDX2024-05-17
04719894432236BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432243BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432250BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432267BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432274BiotequeBioteque Taiwan Ltd.HDX2024-04-08
04719894432281BiotequeBioteque Taiwan Ltd.HDX2024-04-08