Identity
- Trade Name
- Galileo Colposcope, Direct Access FDA UDI
- Generic Name
- Colposcope FDA UDI
- Model / Reference
- 400DA-T FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNX400DAT0 FDA UDI
- FDA Product Code
- HEX FDA UDI
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1630 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colposcope
Galileo Colposcope, Direct Access by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colposcope.
- MICROSCOPE Colposcope — Ecleris · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- MICROSTAR Colposcope — Ecleris · Class II
- MICROSCOPE Colposcope — Ecleris · Class II
- WALLACH — CooperSurgical, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- LEISEGANG — CooperSurgical, 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
- Gynex Corporation
Sources (1)
- FDA UDI 8760df6f-8430-42d2-bef5-e0c5c62be303 32 fields · synced May 30, 2026