n.a.
- Primary DI
- 04048551325971
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 40800021
- Device description
- Navigation-Panel
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| HAW | Neurological stereotaxic Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551325971 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551325971 | 04048551325971 | 4048551325971 |
GMDN Terms#
| Term | Definition |
|---|---|
| Optical surgical navigation/tracking system workstation, mobile | An electrically-powered component of an optical surgical navigation and/or tracking system intended to act as the user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a mobile (on wheels) computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software; it may be a stand-alone unit or integrated into an endoscopic video tower or surgical pendant. The system provides an optical tool for the tracking of instruments and the patient, and may be intended to facilitate overlay of pre-acquired images [e.g., computed tomography (CT)] or real-time image data [e.g., ultrasound (US)]. |
Regulatory Flags#
- DUNS number
- 315731430
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04048551415320 | n.a. | WD300 | WD300 | 2024-12-12 |
| 04048551411704 | NA | UF101 | UF101 | 2025-03-27 |
| 04048438006368 | n.a. | 030647-10 | 030647-10 | 2020-01-11 |
| 04048438006429 | n.a. | 031529-10 | 031529-10 | 2020-01-11 |
| 04048438006306 | n.a. | 031523-10 | 031523-10 | 2019-02-23 |
| 04048551440148 | n.a. | 091010-10 | 091010-10 | 2026-10-16 |
| 04048551444559 | n.a. | 091011-10 | 091011-10 | 2026-10-16 |
| 04048551423226 | HD-VIEW | 11272VH | 11272VH | 2020-01-11 |
| 04048551423363 | HD-VIEW | 11272VHU | 11272VHU | 2020-01-11 |
| 04048551161005 | n.a. | 40800110 | 2018-09-04 | |
| 04048551291030 | NAV1 | 40810020 | 2018-08-23 | |
| 04048551160992 | n.a. | 40800090 | 2016-09-23 | |
| 04048551277577 | n.a. | 40812020 | 2018-08-21 | |
| 04048551325988 | n.a. | 40800051 | 2016-09-23 | |
| 04048551336854 | NAV1 | 40820020 | 2018-08-23 | |
| 04048551337707 | n.a. | 40820086 | 2018-08-17 | |
| 04048551337820 | NAV1 | 40820030 | 2018-08-23 | |
| 04048551271087 | n.a. | 40800120 | 2016-09-23 | |
| 04048551387344 | n.a. | 40820123 | 2019-02-23 | |
| 04048551387368 | n.a. | 40820150 | 2017-03-17 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07340201503829 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-20 |
| 07340201503836 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-20 |
| 07340201503843 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-20 |
| 07340201503850 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-20 |
| 07340201503867 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-20 |
| 07340201503812 | Leksell Neurosurgical Instruments | Elekta Solutions AB | HAW | 2026-10-19 |
| 00889024713895 | ROSA ONE BRAIN APPLICATION (US) | MEDTECH | HAW | 2026-09-28 |
| 00889024714113 | PLANNING STATION - USA | MEDTECH | HAW | 2026-09-28 |
| 00889024704213 | PLANNING STATION - USA | MEDTECH | HAW | 2026-02-23 |
| 04056481146702 | Curve Navigation | Brainlab SE | HAW | 2025-10-13 |
| 00889024679559 | ALLEN WRENCH 8MM | MEDTECH | HAW | 2025-07-15 |
| 00887868539978 | SEEG DRILL ADAPTOR 2.70MM | MEDTECH | HAW | 2025-06-24 |
| 00889024663282 | PLANNING STATION - ROSA ONE - USA | MEDTECH | HAW | 2024-02-20 |
| 00887868585951 | ROSA ONE BRAIN APPLICATION (US) | MEDTECH | HAW | 2023-10-30 |
| 03760244031129 | Trnsnsl Endscp Ovoid Ø6.18mm Holder | MEDTECH | HAW | 2023-10-27 |
| 04056481144500 | Curve Navigation 17700 | Brainlab SE | HAW | 2023-05-22 |
| 03760244034793 | ROSA ONE SURGICAL ASSISTANT (US) | MEDTECH | HAW | 2022-06-20 |
| 03760244034922 | PLANNING STATION-ROSA ONE- USA | MEDTECH | HAW | 2022-06-20 |
| 03760244035127 | PLANNING STATION-ROSA ONE- USA | MEDTECH | HAW | 2022-06-20 |
| 03760244034625 | SEEG DRILL ADAPTOR Ø2.5MM | MEDTECH | HAW | 2022-02-18 |
| 03760244034632 | SEEG DRILL ADAPTOR Ø2.15MM | MEDTECH | HAW | 2022-02-18 |
| 03760244034649 | SEEG DRILL ADAPTOR Ø2.45MM | MEDTECH | HAW | 2022-02-18 |
| 03760244034656 | SEEG DRILL ADAPTOR Ø2.55MM | MEDTECH | HAW | 2022-02-18 |
| 03760244034663 | SEEG DRILL ADAPTOR Ø3.2MM | MEDTECH | HAW | 2022-02-18 |
| 03760244032195 | Optical distance sensor | MEDTECH | HAW | 2021-06-15 |
| 03760244034304 | ROBOT ROSA ONE (USA) | MEDTECH | HAW | 2021-05-31 |
| 03760244034403 | PLANNING STATION Rosa One -USA | MEDTECH | HAW | 2021-05-31 |
| 04056481143503 | Kick 2 Navigation Station | Brainlab SE | HAW | 2021-05-31 |
| 03760244030962 | CRW frame adaptor | MEDTECH | HAW | 2020-11-20 |
| 03760244031914 | LEKSELL FRAME REGISTRATION PLATES | MEDTECH | HAW | 2020-10-20 |