Identity
- Trade Name
- Vaginal Dilator 3er Set large FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina, lichen sclerosus - 3er set with the sizes 3, 4 and 5 FDA UDI
- Model / Reference
- Vagiwell L FDA UDI
- Description
- Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina, lichen sclerosus - 3er set with the sizes 3, 4 and 5 FDA UDI
Identifiers
- Catalog Number
- Vagiwell L FDA UDI
- Primary DI / UDI-DI
- 04013273001571 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal dilator
Vaginal Dilator 3er Set large by KESSEL medintim GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vaginal dilator.
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- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- ELMED INCORPORATED — ELMED INCORPORATED · Class I
- GEN2 — SURGIX MEDICAL LLC · Class I
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
- KESSEL medintim GmbH
Sources (1)
- FDA UDI 63c9ee43-ec33-4d2c-b71c-24f418928719 35 fields · synced May 30, 2026