Identity
- Trade Name
- REBLOOM GRS VAGINAL TRAINERS FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- • 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. FDA UDI
- Model / Reference
- RGVT-38100 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719961531008 FDA UDI
- FDA Product Code
- HDQ FDA UDI
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vaginal dilator
Rebloom Grs Vaginal Trainers by Gshen medical CO., LTD. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gshen medical CO., LTD.
Sources (1)
- FDA UDI d4a2be35-df45-41c3-9bdb-1dfa15849377 34 fields · synced May 31, 2026