Identity
- Trade Name
- Marina Medical FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Hawkin Ambler Dilator - Single Ended, Size 14/17mm, 18.75cm/7.5in FDA UDI
- Model / Reference
- 260-414 FDA UDI
- Description
- Hawkin Ambler Dilator - Single Ended, Size 14/17mm, 18.75cm/7.5in FDA UDI
Identifiers
- Catalog Number
- 260-414 FDA UDI
- Primary DI / UDI-DI
- 00840306826443 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 7.5 Centimeter FDA UDI
Category: Vaginal dilator
Marina Medical by Marina Medical Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal dilator.
- 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
- ELMED INCORPORATED — ELMED INCORPORATED · Class I
- GEN2 — SURGIX MEDICAL LLC · Class I
- ELMED INCORPORATED — ELMED INCORPORATED · Class I
- LANDANGER — LANDANGER · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Marina Medical Instruments, Inc.
Sources (1)
- FDA UDI 0cda199e-35f4-460b-80df-ccc41c8b9f2a 36 fields · synced May 30, 2026