GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC.

FDA Device Registration & Listing · Hillsboro, OR, US · Registration 3005489143

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
3005489143
FEI Number
3005489143
Entity Name
GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC.
City/State/Country
Hillsboro, OR, US
Establishment Address
5295 NE Elam Young Pkwy, STE 140, Hillsboro, OR 97124, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gunther Weiss Scientific Glassblowing Co., Inc. (Owner Number: 10028082)
Owner / Operator Contact Address
5295 NE Elam Young Pkwy, STE 140, Hillsboro, OR 97124, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Retractor, Ophthalmic Baylis WEISS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2024-08-25
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2022-02-17

Official Correspondent

Scott Wheeler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gunther Weiss Scientific Glassblowing Co., Inc.
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
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009 Becton Dickinson and Company 1
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005489143. Last updated year: 2026. Please use registration number 3005489143 when referencing this establishment in official correspondence.
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