Bioseal

FDA Device Registration & Listing · Grapevine, TX, US · Registration 3043620414

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
3043620414
FEI Number
3043620414
Entity Name
Bioseal
City/State/Country
Grapevine, TX, US
Establishment Address
801 Industrial Blvd Ste 100, Grapevine, TX 76051, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BIOSEAL (Owner Number: 2027062)
Owner / Operator Contact Address
167 WEST ORANGETHORPE AVE., --, Placentia, CA 92870, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surgery Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2007-11-09

Official Correspondent

WILLIAM RUNION

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
2027062 BIOSEAL PLACENTIA, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K961683 J.J. Skinner, Inc. JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY 1996-05-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025 Windstone Medical Packaging, Inc. 2
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021 Alcon Research, LLC 2
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043620414. Last updated year: 2026. Please use registration number 3043620414 when referencing this establishment in official correspondence.
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