FDA Registration
Active
🇺🇸 United States
GEODIS
Reg #: 3008087383
·
FEI: 3008087383
·
Expires 2026
Products
10
Proprietary Names
12
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- GEODIS
- Registration Number
- 3008087383
- FEI Number
- 3008087383
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 450 Lillard Drive
- City
- Sparks
- State
- NV
- ZIP
- 89434
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153341
Owner / Operator
- Firm Name
- GEODIS
- Operator Number
- 10030802
- Address
- 450 Lillard Drive
- City
- Sparks
- State
- NV
- Postal Code
- 89434
- Country
- US
- Correspondent
- Christine M Vestbie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2024-11-04 |
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2024-11-04 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2024-11-04 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-11-04 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2024-11-04 |
| Device, Dermal Replacement | MDD | Class 3 | Unknown | No | 2016-06-01 |
| Dressing, Wound And Burn, Interactive | MGR | Class 3 | Unknown | No | 2016-06-01 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2015-12-14 |
| Balloon, Nasal Airway | QGK | Class 1 | Ear, Nose, Throat | No | 2024-11-04 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2024-11-04 |
Proprietary Names
SMS 1 PACK US - PCCR
AERA WITH VENT CAP
TruDi Probe
TruDi Shaver Blade
SPINPLUS 3-GUIDE
INSPIRA AIR Balloon Dilation System
TRUDI NAV CABLE
TruDi Curette
RELIEVA TRACT
Hermetic Large Style Ventricular Catheter Set
LUMA SENTRY
MoniTorr ICP¿ External CSF Drainage and Monitoring System with Patient Line One Way Valve
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)