Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1418005

FEI Number

3003243311

Entity Name

AMCOR FLEXIBLES, LLC

City/State/Country

MUNDELEIN, IL, US

Establishment Address

1919 S Butterfield Rd, MUNDELEIN, IL 60060, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amcor Flexibles (Owner Number: 9059465)

Owner / Operator Contact Address

1919 South Butterfield Rd., Mundelein, IL 60060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TYVEK Pouch/Roll with STERRAD Chemical Indicator TYVEK Pouch/Roll with STERRAD Chemical Indicator TYVEK Pouch/Roll with STERRAD Chemical Indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-02-07
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2013-02-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-02-07
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2013-02-07
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2013-09-27

Official Correspondent

Brian Foley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Amcor Flexibles

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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1418005. Last updated year: 2026. Please use registration number 1418005 when referencing this establishment in official correspondence.