Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680741

FEI Number

3005601686

Entity Name

NOUVAG AG

City/State/Country

GOLDACH Sankt Gallen, CH

Establishment Address

ST. GALLERSTRASSE 25, GOLDACH Sankt Gallen 9403, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

NOUVAG AG (Owner Number: 9008454)

Owner / Operator Contact Address

ST. GALLERSTRASSE 25, --, GOLDACH, CH-SG 9403, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultraneb Meshgraft Tissue Expansion System Meshboard Blades for dermatome and mucotome Dermatome Mucotome HighSurg 30 HighTorQ HighSurg 11 Infiltration Tubing Set Tubing Set Irrigation Tubing Set Saw blades MSS 5000 Micro compass saw OMS 5000 Micro oscillating saw MOS 5000 Sagittal micro saw Suction tube Vacuson 40 Vacuson 60 Spinal Burr handpiece 1910 Burr, drill general surgery HighSurg 11 HighSurg 30 Spinal burr TCM 3000 BL Clip for external cooling CHP Handpiece Craniotom drill Dispenser DP 30 Dispenser DP 30 LipoPlus LipoSurg MD 11 Handpieces ENT MD 30 HighSurg 11 HighSurg 30 Liposuction cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-09-04
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2015-09-07
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2010-01-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-07-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2017-02-20
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2010-01-29
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2018-08-10
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2007-10-29
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2004-08-12
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-07-02
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2007-10-30
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2007-10-29
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2007-10-29
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2007-10-29
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2007-10-29
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

Kenneth Block Business: Ken Block Consulting LLC Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

NOUVAG AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680741. Last updated year: 2026. Please use registration number 9680741 when referencing this establishment in official correspondence.