Identity
- Trade Name
- STRADIS HEALTHCARE FDA UDI
- Generic Name
- Pain management medication delivery system FDA UDI
- Model / Reference
- 570-3237 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M75257032370 FDA UDI
- FDA Product Code
- OGJ FDA UDI
- GMDN Term
- Pain management medication delivery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5140 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pain management medication delivery system
Stradis Healthcare by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pain management medication delivery system.
- Hands Free Syringe — CONCERT MEDICAL, LLC · Class II
- Hands Free Syringe — BLUEFIN MEDICAL LLC · Class II
- Hands Free Syringe — CONCERT MEDICAL, LLC · Class II
- Hands Free Syringe — BLUEFIN MEDICAL LLC · Class II
- Hands Free Syringe — BLUEFIN MEDICAL LLC · Class II
- Hands Free Syringe — CONCERT MEDICAL, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stradis Medical, Llc
Sources (1)
- FDA UDI e05195b2-f47f-4e70-a410-1e1b759df499 33 fields · synced May 30, 2026