Identity
- Trade Name
- Laminaria FDA UDI
- Generic Name
- Hygroscopic cervical dilator FDA UDI
- Model / Reference
- 16-104 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNX161041 FDA UDI
- FDA Product Code
- HDY FDA UDI
- GMDN Term
- Hygroscopic cervical dilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Hygroscopic cervical dilator
Laminaria by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hygroscopic cervical dilator.
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- Bioseal Inc. — BIOSEAL · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Gynex Corporation
Sources (1)
- FDA UDI 609adc4a-79c1-4cc7-829c-72117d731820 32 fields · synced May 31, 2026