Identity
- Trade Name
- STRADIS FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Device Name
- CUSTOM SURGICAL KIT - EYE BANK PACK FDA UDI
- Model / Reference
- 689-369 FDA UDI
- Description
- CUSTOM SURGICAL KIT - EYE BANK PACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- M752689369 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 f066d4a7-3778-4ac3-86a0-59a551a26ab5 35 fields · synced May 31, 2026