Identity
- Trade Name
- Eversense Insertion Tools Tray FDA UDI
- Generic Name
- Subcutaneous implantation kit, non-medicated FDA UDI
- Device Name
- The Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dissector. The tray is a component of the Insertion Tools Kit that is used for Sensor insertion and removal. FDA UDI
- Model / Reference
- 101973-010 FDA UDI
- Description
- The Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dissector. The tray is a component of the Insertion Tools Kit that is used for Sensor insertion and removal. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00817491022493 FDA UDI
- PMA Number
- P160048 FDA UDI
- FDA Product Code
- QHJ FDA UDIQCD 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 Insertion Tools Tray 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 E3 Insertion Tools Kit — 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 Insertion Tools Kit — 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
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 |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 23dfcc59-3dab-4347-8b6a-5419b93e7820 37 fields · synced May 30, 2026