REBLOOM GRS VAGINAL TRAINERS

GUDID 04719961531503

• 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

Gshen medical CO., LTD.

Vaginal dilator

• Primary Device ID: 04719961531503
• NIH Device Record Key: 14a50056-7131-4be7-9e01-434ee34fdac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REBLOOM GRS VAGINAL TRAINERS
• Version Model Number: RGVT-38150
• Company DUNS: 658713238
• Company Name: Gshen medical CO., LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com
• Phone: +886227667699
• Email: customerservice@gshenmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719961531503 [Primary]

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [REBLOOM GRS VAGINAL TRAINERS]

• 04719961531503: • The Rebloom GRS Vaginal Trainer is intended for post-gender reassignment surgery (GRS) to ai
• 04719961531008: • The Rebloom GRS Vaginal Trainer is intended for post-gender reassignment surgery (GRS) to ai
• 04719961530506: • The Rebloom GRS Vaginal Trainer is intended for post-gender reassignment surgery (GRS) to ai