Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031481777

FEI Number

3031481777

Entity Name

Wacker Silicone Manufactured Innovations LLC

City/State/Country

Allentown, PA, US

Establishment Address

999 Postal Rd, Allentown, PA 18109, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wacker Silicone Manufactured Innovations LLC (Owner Number: 10091011)

Owner / Operator Contact Address

999 Postal Road, Allentown, PA 18109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rylon-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-06-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wacker Silicone Manufactured Innovations LLC

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 3031481777. Last updated year: 2026. Please use registration number 3031481777 when referencing this establishment in official correspondence.