# Monteris Medical Corp (repackager or relabeler, Minnetonka, MN): 1 new FDA device listing, incl. drills, burrs, trephines & accessories (simple, powered)

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Monteris Medical Corp |
| Role | Repackager or relabeler |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device |
| Location | Minnetonka, MN, US |
| New listings | 1 |
| Devices | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Product codes | HBE |
| Device classes | Class II |
| Medical specialties | Neurology |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-05-19 |
| FDA registration number | 3009970070 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.