FDA device listing
ABDUCTION PILLOW,Alum. Structure for ARC Brace,Arc. ArmSlin/Ball/Hip Piece Lg,Arc ArmSlin/Ball/Hip Piece Std,Arc. Deluxe…
FDA device listing 1898344064 · TIBURON MEDICAL ENTERPRISES
Key facts
| Proprietary names | ABDUCTION PILLOW,Alum. Structure for ARC Brace,Arc. ArmSlin/Ball/Hip Piece Lg,Arc ArmSlin/Ball/Hip Piece Std,Arc. Deluxe Sling, one size,Arc HipSec Shldr B Bnd2Fit Std,Cast Sling, Universal,Liner, Arc. Deluxe Sling OneSz,Repl Soft Goods, Arc Large,Repl Soft Goods, Arc Std,Shoulder Immobilizer Sling, Extra Large,Shoulder Immobilizer Sling, Extra Small,SHOULDER IMMOBILIZER SLING, LL,SHOULDER… |
|---|---|
| Owner/operator | TIBURON MEDICAL ENTERPRISES |
| Owner/operator number | 9040187 |
| Product codes | ILI |
| Device names | ILI - Sling, Arm |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3640 |
| Review panels | Physical Medicine |
| Registered establishments | TIBURON MEDICAL ENTERPRISES, Zeffer Research & Assoc. S. A. de C. V. |
| Establishment registrations | 2031918, 3007392395 |
| FEI numbers | 3002935344, 3007392395 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database