Identity
- Trade Name
- Endocervical Speculum FDA UDI
- Generic Name
- Manual expandable cervical dilator FDA UDI
- Model / Reference
- 2040 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNX20400 FDA UDI
- FDA Product Code
- FXE FDA UDI
- GMDN Term
- Manual expandable cervical dilator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 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
No
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
Category: Manual expandable cervical dilator
Endocervical Speculum by Gynex Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual expandable cervical dilator.
- Endocervical Speculum — CooperSurgical, Inc. · Class I
- LEEP Endocervical Speculum — CooperSurgical, Inc. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- LEEP Endocervical Speculum — CooperSurgical, Inc. · Class I
- Endocervical Speculum, Ratchet Handle — GYNEX CORPORATION · Class I
- Endocervical Speculum, Ratchet Handle — GYNEX CORPORATION · Class I
- Endocervical Speculum — GYNEX CORPORATION · 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
- Gynex Corporation
Sources (1)
- FDA UDI 8c3190f3-df4d-4f2d-8669-89b98fa6305b 32 fields · synced May 30, 2026