Identity
- Trade Name
- MedGyn Laminaria FDA UDI
- Generic Name
- Hygroscopic cervical dilator FDA UDI
- Device Name
- Dilator of uterine cervix FDA UDI
- Model / Reference
- size 5 long FDA UDI
- Description
- Dilator of uterine cervix FDA UDI
Identifiers
- Catalog Number
- 021015 FDA UDI
- Primary DI / UDI-DI
- M803021015 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Hygroscopic cervical dilator
MedGyn Laminaria by Medgyn Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hygroscopic cervical dilator.
- Laminaria — GYNEX CORPORATION · Class II
- Laminaria — GYNEX CORPORATION · Class II
- Laminaria — GYNEX CORPORATION · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
- MedGyn Laminaria — MEDGYN PRODUCTS, INC. · Class II
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
- Medgyn Products, Inc.
Sources (1)
- FDA UDI 4e790008-1142-4952-bcc9-e2c958e55302 34 fields · synced May 30, 2026