Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010134099

FEI Number

3010134099

Entity Name

Tanis, Inc.

City/State/Country

Delafield, WI, US

Establishment Address

3660 Kettle Ct E, Delafield, WI 53018, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tanis Incorporated (Owner Number: 10082844)

Owner / Operator Contact Address

3660 Kettle Court East, Delafield, WI 53018, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tanis Brush Tanis Brush Tanis Brush Tanis Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2021-10-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-10-07
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2021-10-07
MJI	Specimen/Tissue, Identification Orientation	Pathology	Class 1	864.3010	2024-04-11

Official Correspondent

Matt Schultz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tanis Incorporated

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3016965567	SAETTELE GMBH & CO. KG	Todtnau Baden-Wurttemberg, DE
3004091741	AXEL GENTNER GMBH	Tuttlingen Baden-Wurttemberg, DE
3011178147	GI SCIENTIFIC LLC	Mc Lean, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010134099. Last updated year: 2026. Please use registration number 3010134099 when referencing this establishment in official correspondence.