PTI Engineered Plastics

FDA Device Registration & Listing · Macomb, MI, US · Registration 3007238674

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
3007238674
FEI Number
3007238674
Entity Name
PTI Engineered Plastics
City/State/Country
Macomb, MI, US
Establishment Address
50900 Corporate Drive, Macomb, MI 48044, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PTI Engineered Plastics (Owner Number: 10022700)
Owner / Operator Contact Address
50900 Corporate Drive, Macomb Township, MI 48044, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bed Rail Assembly, Patient Monitoring

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-01-17
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2007-10-10
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2007-10-10

Official Correspondent

Connie Share

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PTI Engineered Plastics
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007238674. Last updated year: 2026. Please use registration number 3007238674 when referencing this establishment in official correspondence.
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