QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V.

FDA Device Registration & Listing · CUAUHTEMOC, CHIHUAHUA Mexico, MX · Registration 8030678

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
8030678
FEI Number
3008373372
Entity Name
QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V.
City/State/Country
CUAUHTEMOC, CHIHUAHUA Mexico, MX
Establishment Address
AVE. RIO STA. CLARA - LOTES 12 y 13 S/N, PARQUE INDUSTRIAL CUAUHTEMOC, CUAUHTEMOC, CHIHUAHUA Mexico 31543, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cardinal Health 200, LLC (Owner Number: 9028292)
Owner / Operator Contact Address
3651 Birchwood Drive, --, Waukegan, IL 60085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K955556
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2014-07-30
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-15
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2022-07-20
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-15
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2006-04-11
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-05-12
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2017-08-11
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2009-05-06
ERY Drape, Surgical, Ent General, Plastic Surgery Class 2 878.4370 2017-08-07
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-08-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-07-31
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2015-06-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004839227 Cardinal Health Malta 212 Ltd Marsa, MT
3015541720 Cardinal Health Germany Manufacturing GmbH Halberstadt Saxony-Anhalt, DE
1033903 Cardinal Health Greenwood, SC, US
9611018 Cardinal Health Ireland Manufacturing Limited TULLAMORE Offaly, IE
8040459 Kendall-Gammatron Limited SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
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-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030678. Last updated year: 2026. Please use registration number 8030678 when referencing this establishment in official correspondence.
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