AccessGUDID - DEVICE: Hope&Her Vaginal Dilators (00860012225002)

GUDID

Device Identifier (DI) Information

Brand Name: Hope&Her Vaginal Dilators
Version or Model: T8077
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LUJENA, INC.

Primary DI Number: 00860012225002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080271509 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11267	Vaginal dilator	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDX	Dilator, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: A. 0.6" Diameter x 3.48" Length
Device Size Text, specify: B. 0.88" Diameter x 3.97" Length
Device Size Text, specify: C. 1.04" Diameter x 4.46" Length
Device Size Text, specify: D. 1.19" Diameter x 4.95" Length
Device Size Text, specify: E. 1.35" Diameter x 5.45" Length
Device Size Text, specify: F. 1.5" Diameter x 5.96" Length
Device Size Text, specify: Universal Handle fits all sizes

Device Record Status

Public Device Record Key: 7849694c-e2bf-4b50-9744-f762e686e8ec
Public Version Date: January 27, 2025
Public Version Number: 2
DI Record Publish Date: November 15, 2024