Identity
- Trade Name
- STRADIS FDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- STERILE SEPARTES-CONDUCTIVITY GEL FDA UDI
- Model / Reference
- 525-035 FDA UDI
- Description
- STERILE SEPARTES-CONDUCTIVITY GEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7525250351 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Commercial Distribution
- Not 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
Stradis by Stradis Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Stradis Medical, Llc
Sources (1)
- FDA UDI 5e26cbee-34b9-44b7-8506-23b8fbf909e5 35 fields · synced Jun 1, 2026