GEODIS

FDA Device Registration & Listing · Sparks, NV, US · Registration 3008087383

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008087383
FEI Number
3008087383
Entity Name
GEODIS
City/State/Country
Sparks, NV, US
Establishment Address
450 Lillard Drive, Sparks, NV 89434, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
GEODIS (Owner Number: 10030802)
Owner / Operator Contact Address
450 Lillard Drive, Sparks, NV 89434, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201174
PMA Number
N/A

All Registered Proprietary Names

SMS 1 PACK US - PCCR AERA WITH VENT CAP SMS 1 PACK US - PCCR TruDi Probe TruDi Shaver Blade SPINPLUS 3-GUIDE INSPIRA AIR Balloon Dilation System TRUDI NAV CABLE TruDi Curette

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2024-11-04
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2024-11-04
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2024-11-04
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2024-11-04
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2024-11-04
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-11-04
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2024-11-04
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2024-11-04
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2024-11-04
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2024-11-04

Official Correspondent

Christine Vestbie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GEODIS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K171761 Acclarent, Inc. ACCLARENT AERA Eustachian Tube Balloon Dilation System 2018-01-16
K200041 Fiagon GmbH FlexPointer 1.5 Single Use, FlexTube 3 Single Use 2020-03-10
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17

Similar Registrations

Registration Number Establishment Name Location
3027828125 MAJiK MEDICAL SOLUTIONS PRIVATE LIMITED Hyderabad Telangana, IN
3005440795 XINHUA SURGICAL INSTRUMENT CO. LTD. ZIBO Shandong, CN
2529846 MED SAVER, INC. PHOENIXVILLE, PA, US
3003790304 GYRUS ACMI, INC. Westborough, MA, US
9615857 INSTRUMENTARIUM SURGICAL CORP., INC. TERREBONNE Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008087383. Last updated year: 2026. Please use registration number 3008087383 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.