FDA.reportPublic FDA data

NAV1

Primary DI
04048551291030
Brand
NAV1
Company
Karl Storz GmbH & Co. KG
Model
40810020
Device description
NAV1-Module
Published
2018-08-23
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 table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551291030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551291030040485512910304048551291030

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation/tracking system workstation, stationaryAn electrically-powered component of an optical surgical navigation and/or tracking system intended to serve as a user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a stationary computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software. 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 table
Primary DIBrandModelCatalogPublished
04048551411704NAUF101UF1012025-03-27
04048438006368n.a.030647-10030647-102020-01-11
04048438006429n.a.031529-10031529-102020-01-11
04048438006306n.a.031523-10031523-102019-02-23
04048551440148n.a.091010-10091010-102026-10-16
04048551444559n.a.091011-10091011-102026-10-16
04048551423226HD-VIEW11272VH11272VH2020-01-11
04048551423363HD-VIEW11272VHU11272VHU2020-01-11
04048551161005n.a.408001102018-09-04
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
04048551001141n.a.495NCS2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832797NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
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00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21