Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025168

FEI Number

1000125955

Entity Name

WINDSTONE MEDICAL PACKAGING, INC.

City/State/Country

BILLINGS, MT, US

Establishment Address

1602 4th Ave N, BILLINGS, MT 59101, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Sterilize Medical Device for Another Party (Contract Sterilizer),Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WINDSTONE MEDICAL PACKAGING, INC. (Owner Number: 9001641)

Owner / Operator Contact Address

1602 4th Ave. North, Billings, MT 59101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

D169075

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WINDSTONE MEDICAL PACKAGING, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025686427	Windstone Medical Packaging, Inc.	Billings, MT, US

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-0029-2025	Windstone Medical Packaging, Inc.	1	Aligned Medical Septo Pack REF AMS11480 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.

Similar Registrations

Registration Number	Establishment Name	Location
3016215282	MINDERA CORPORATION	Vista, CA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3022320321	ALIRA MEDICAL DEVICES LLC	Rancho Cucamonga, CA, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025168. Last updated year: 2026. Please use registration number 3025168 when referencing this establishment in official correspondence.