Identity
- Trade Name
- EdgeFlow™ FDA UDI
- Generic Name
- Survivin protein IVD, calibrator FDA UDI
- Device Name
- EdgeFlow E25G-NR Injection needle FDA UDI
- Model / Reference
- EE25GNRIN FDA UDI
- Description
- EdgeFlow E25G-NR Injection needle FDA UDI
Identifiers
- Catalog Number
- EE25GNRIN FDA UDI
- Primary DI / UDI-DI
- 00818365028320 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Survivin protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Survivin protein IVD, calibrator
EdgeFlow™ by US Endodontics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- US Endodontics, LLC
Sources (1)
- FDA UDI 1fdcb666-3eb4-4ec3-9e5f-7afee9180567 35 fields · synced May 30, 2026