Identity
- Trade Name
- Eversense E3 Insertion Tools Kit FDA UDI
- Generic Name
- Subcutaneous implantation kit, non-medicated FDA UDI
- Device Name
- Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal. FDA UDI
- Model / Reference
- FG-8300-01-201 FDA UDI
- Description
- Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal. FDA UDI
Identifiers
- Catalog Number
- FG-8300-01-201 FDA UDI
- Primary DI / UDI-DI
- 00817491022905 FDA UDI
- PMA Number
- P160048 FDA UDI
- FDA Product Code
- QHJ FDA UDI
- GMDN Term
- Subcutaneous implantation kit, non-medicated FDA UDI
Classification
- Device Class
- Class III 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
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
No
FDA UDI
Category: Subcutaneous implantation kit, non-medicated
Eversense E3 Insertion Tools Kit by Senseonics, Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subcutaneous implantation kit, non-medicated.
- Eversense Insertion Tools Kit — SENSEONICS, INCORPORATED · Class III
- Eversense® Insertion Tools Kit — SENSEONICS, INCORPORATED · Class III
- Eversense Insertion Tools Tray — SENSEONICS, INCORPORATED · Class III
Cleared under the same submission
P160048 also covers:
- Eversense Adhesive Patches, 10-pack White — SENSEONICS, INCORPORATED
- Eversense Charging Cable — SENSEONICS, INCORPORATED
- Eversense E3 Adhesive Patches Kit, 180-pack — SENSEONICS, INCORPORATED
- Eversense E3 Pouch Containing Sensor and Holder — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - DME — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - Retail — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit – Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Retail — SENSEONICS, INCORPORATED
- Eversense Insertion Tools Kit — SENSEONICS, INCORPORATED
- Eversense Insertion Tools Tray — SENSEONICS, INCORPORATED
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 5f91607c-7c06-4f6e-88cf-1f3738c32b9a 37 fields · synced May 31, 2026