Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009662229

FEI Number

3009662229

Entity Name

Steribite, LLC

City/State/Country

Wooster, OH, US

Establishment Address

1877 Eagle Pass, Wooster, OH 44691, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Steribite (Owner Number: 10040888)

Owner / Operator Contact Address

1877 Eagle Pass, Wooster, OH 44691, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180949

PMA Number

N/A

All Registered Proprietary Names

STERISHARP STERIBITE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2018-12-07

Official Correspondent

John Redmond

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Steribite

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
8010769	KAPP SURGICAL GMBH	DUERBHEIM Baden-Wurttemberg, DE
8010386	S.U.A. MARTIN GMBH & CO.	RIETHEIM-WEILHEIM Baden-Wurttemberg, DE
9680515	TONTARRA MEDIZINTECHNIK GMBH	WURMLINGEN Baden-Wurttemberg, DE
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009662229. Last updated year: 2026. Please use registration number 3009662229 when referencing this establishment in official correspondence.