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REBLOOM GRS VAGINAL TRAINERS

Gshen medical CO., LTD. · Model RGVT-38100 · UDI-DI 04719961531008

HDQ

510(k) clearances

Adverse events

Recalls

153

Facilities

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.

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23	MEDLINE INDUSTRIES, LP - Northfield	Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2009-04-09	Marina Medical Instruments Inc.	Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was
2009-04-09	Marina Medical Instruments Inc.	Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not p

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.