FDA device listing
120 Reverse Retractor OMiQ,AUFRICHT NASAL RETRACTOR,Curved Spatula OMiQ,Double Langenbeck Retractor OMiQ,Hartmann nasal…
FDA device listing 1302622181 · Schobell Industrial Ltda
Key facts
| Proprietary names | 120 Reverse Retractor OMiQ,AUFRICHT NASAL RETRACTOR,Curved Spatula OMiQ,Double Langenbeck Retractor OMiQ,Hartmann nasal specula n. 1,Hartmann nasal specula n. 2,Hartmann nasal specula n. 3,Killian Speculum n.3,Langenbeck Retractor OMiQ,McIvor Frame for Adults,Mc Ivor mouth gag,McIvor Mouth Gag for Children with 3 Tongue Depressors,McIvor Tongue Depressor n.4,McIvor Tongue Depressor n.5,McIvor… |
|---|---|
| Owner/operator | Schobell Industrial Ltda |
| Owner/operator number | 10059048 |
| Product codes | KAL |
| Device names | KAL - Retractor, Ent |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | SCHOBELL INDUSTRIAL LTDA |
| Establishment registrations | 5906 |
| FEI numbers | 5906 |
| Establishment operations | 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