REBLOOM GRS VAGINAL TRAINERS

Basic Information

• Brand Name: REBLOOM GRS VAGINAL TRAINERS
• Primary DI: 04719961531503
• Version / Model: RGVT-38150
• Company Name: Gshen medical CO., LTD.
• Labeler DUNS: 658713238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-25
• Public Version: 1
• Public Version Date: 2025-05-05
• Public Version Status: New
• Public Device Record Key: 14a50056-7131-4be7-9e01-434ee34fdac3

Device Description

• The Rebloom GRS Vaginal Trainer is intended for post-gender reassignment surgery (GRS) to aid in postoperative vaginal dilation therapy. Utilizing balloon dilation technology, it effectively reduces the pain and discomfort associated with conventional rigid dilators. • Material: Polyurethane • The product consists of three main components: a balloon catheter, extension tubing, and a two-way stopcock. The balloon catheter consists of a tip, connecting tube, balloon, catheter, and catheter hub. It is suitable for patients requiring gradual vaginal tissue expansion

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719961531503	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]