MACO BAG CORP.

FDA Device Registration & Listing · Newark, NY, US · Registration 3001468798

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
3001468798
FEI Number
2000020733
Entity Name
MACO BAG CORP.
City/State/Country
Newark, NY, US
Establishment Address
412 van Buren St, Newark, NY 14513, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MACO BAG CORP. (Owner Number: 1316093)
Owner / Operator Contact Address
412 Van Buren Street, Newark, NY 14513, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ScanX Barrier Envelope: G8511-0, G8511-1, G8511-2, G8511-2k, G8511-3, G8511-4 ScanX Barrier Envelopes: 73248-0, 73248-1, 73248-2, 73248-2k, 73248-3, 73248-4. Durr 0238-2207-010-01 Bite Cover Durr 0238-2130-071-01 Size 1 100/pk Durr 0238-2130-080-05 Size 0 Coex Air Techniques 73066/2 Size 6 Durr 0238-2130-083-01 Size 3 Durr 0238-2130-070-05 Size 0 Coex 100/pk Durr 2130107001 Size 0 0238-G8511-0 Durr 0238-2134-085-00 Size 5 Air Techniques 73248-1 Size 1 Durr 2130107204 Size 2K 0238-G8511-2K Air Techniques 73248-3 Size 3 Air Techniques 73248-2k Size 2 Bulk Durr 0238-2130-072-04 Size 2 500 Clamshell Durr 0238-2130-084-01 Size 4 Durr 0238-2130-070-01 Size 0 100/pk Air Techniques 73248-4 Size 4 Air Techniques A7395-2 Bite Covers Durr 0238-2140-074-01 Size 4 New 100/pk Durr 2130107301 Size 3 0238-G8511-3 Durr 0238-2130-081-01 Size 1 Durr 0238-2130-080-01 Size 0 Durr 0238-2130-073-01 Size 3 100/pk Durr 0238-2130-082-05 Size 2 Coex Durr 0238-2130-082-01 Size 2 Durr 0238-2130-070-06 Size 0 New Durr 2130107401 Size 4 0238-G8511-4 Durr 2130107204 Size 2 0238-G8511-2 Durr 2130107101 Size 1 0238-G8511-1 Durr 0238-2130-072-06 Size 2 300/pk - New Labels Durr 0238-2130-072-01 Size 2 300/pk Durr 0238-2130-074-01 Size 4 100/pk Durr 0238-2130-082-04 Size 2 Bulk Air Techniques 73248-2 Size 2 Air Techniques 73248-0 Size 0

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2019-07-29
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2019-02-06

Official Correspondent

Mike Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001468798. Last updated year: 2026. Please use registration number 3001468798 when referencing this establishment in official correspondence.
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