Identity
- Trade Name
- Amielle FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Amielle Cone Size 4 is intended to be inserted into the vagina and progressively dilate the vagina FDA UDI
- Model / Reference
- SM 2174 FDA UDI
- Description
- Amielle Cone Size 4 is intended to be inserted into the vagina and progressively dilate the vagina FDA UDI
Identifiers
- Catalog Number
- SM 2174 FDA UDI
- Primary DI / UDI-DI
- 00384702174017 FDA UDI
- 510(k) Number
- K983045 FDA UDI
- FDA Product Code
- KXP FDA UDI
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3900 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 160 Millimeter FDA UDI
Category: Vaginal dilator
Amielle by Owen Mumford Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal dilator.
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- ELMED INCORPORATED — ELMED INCORPORATED · Class I
- DILATOR — KLS-Martin L.P. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- ELMED INCORPORATED — ELMED INCORPORATED · Class I
- GEN2 — SURGIX MEDICAL LLC · Class I
Cleared under the same submission
K983045 also covers:
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD LIMITED
- Amielle — OWEN MUMFORD USA INCORPORATED
- Amielle — OWEN MUMFORD USA INCORPORATED
- Amielle — OWEN MUMFORD USA INCORPORATED
- Amielle — OWEN MUMFORD USA INCORPORATED
- Amielle — OWEN MUMFORD USA INCORPORATED
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Owen Mumford Limited
Sources (1)
- FDA UDI 2cb4566c-011d-4e39-8921-734b0aeffd78 38 fields · synced May 31, 2026