Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005858760

FEI Number

3015190887

Entity Name

Packaging Corporation of America

City/State/Country

Hanover, PA, US

Establishment Address

401 Moulstown Rd, Hanover, PA 17331, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Packaging Corporation of America (Owner Number: 10053781)

Owner / Operator Contact Address

401 Moulstown Rd, Hanover, PA 17331, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Simply Saline Mighty Patch Mighty Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2026-04-28
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-04-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-04-28

Official Correspondent

Bryan Harber

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Packaging Corporation of America

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3008731457	LIQUIDIA TECHNOLOGIES INC	Morrisville, NC, US
3015277897	FUTURE VISION FOR IMPORT AND EXPORT OF MEDICAL AND PHARMACEUTICAL PRODUCTS LIMITED	ISTANBUL, TR
3005721395	LABORATORIO PABLO CASSARA	Caba Buenos Aires, AR
3031820558	BIGDAM INC	Atlanta, GA, US
3009141067	DOLOR TECHNOLOGIES LLC	Syracuse, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005858760. Last updated year: 2026. Please use registration number 3005858760 when referencing this establishment in official correspondence.