Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001397320

FEI Number

3001397320

Entity Name

ROECHLING MEDICAL ROCHESTER L.P.

City/State/Country

Rochester, NY, US

Establishment Address

999 RIDGEWAY AVE, Rochester, NY 14615, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Roechling Medical Rochester, L.P. (Owner Number: 10048821)

Owner / Operator Contact Address

999 Ridgeway Ave, Rochester, NY 14615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

304.104W 304.106W 304.116W 304.126 304.140 304.112W 304.105W FSM - TRAY, SURGICAL, INSTRUMENT 304.138 304.108W 304.127 304.114W 304.134 304.102W 304.124 304.122 304.118W 304.110W 304.136 304.120W 304.132 304.120 304.125 304.107W 304.130 304.128 304.103W

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-04-19

Official Correspondent

Colin McGrath

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Roechling Medical Rochester, L.P.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2531321	Roechling Medical Lancaster, LLC	DENVER, PA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001397320. Last updated year: 2026. Please use registration number 3001397320 when referencing this establishment in official correspondence.