Ear, Nose, and Throat Stereotaxic Instrument
The Karl Storz sterile adhesive pad is a single-use patient-tracker accessory for the NAV1 electromagnetic navigation system. It provides an adhesive mounting surface for the patient…
The Karl Storz sterile adhesive pad is a single-use patient-tracker accessory for the NAV1 electromagnetic navigation system. It provides an adhesive mounting surface for the patient tracker during the image-guided navigation setup.
The NAV1 system links a tracked instrument and patient reference to the patient’s CT or MRI image space. The filed package contains twenty sterile pads for use as disposable tracker attachments.
Listed Item
Adhesive Pad, sterile, package of 20
Navigation Reference
The pad provides the adhesive mounting surface for the NAV1 patient tracker. The tracker supplies a patient reference while the navigation system relates tracked instruments to stored CT or MRI images.
This sterile, single-use accessory belongs to the patient-tracking part of the navigation setup. It is supplied as a pack of twenty pads for use with the NAV1 system.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Record published | 2016-12-22 |
| Record revised | 2024-10-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40820600 | In distribution | ||
| 40820132 | In distribution | ||
| 40820160 | In distribution | ||
| 40800084 | In distribution | ||
| 40820140 | In distribution | ||
| 40820086 | In distribution | ||
| 40820145 | In distribution | ||
| 40820105 | In distribution | ||
| 40820131 | In distribution | ||
| 40820084 | 20 | In distribution | |
| 40820110 | In distribution | ||
| 40820111 | In distribution | ||
| 40820130 | In distribution | ||
| 40820150 | In distribution | ||
| 40820112 | In distribution | ||
| 40820165 | In distribution | ||
| 40820123 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StealthStation | Medtronic Navigation, Inc. | 17 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 14 |
| Ear, Nose, And Throat Stereotaxic Instrument | Medtronic Navigation, Inc. | 13 |
| Ear, Nose, And Throat Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 12 |
| StealthStation Cranial Software | Medtronic Navigation, Inc. | 11 |
| AxiEM™ | Medtronic Navigation, Inc. | 10 |
| Profess | Stryker Leibinger Gmbh & Co. KG | 8 |
| TGS | Stryker GmbH | 6 |
| StealthStation S8 | Medtronic Navigation, Inc. | 5 |
| TruDi Probe | Acclarent, Inc. | 4 |
| TruDi Shaver Blade | Acclarent, Inc. | 4 |
| Scopis | Stryker Leibinger Gmbh & Co. KG | 3 |
Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.