FDA.report

NA

Primary DI
00643169777316
Brand
NA
Company
MEDTRONIC NAVIGATION, INC.
Model
9734048R
Device description
PLNG STATION 9734048R STEALTHSTATION S7
Published
2017-02-18
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

Related Records

Contact Domains

Product Codes

CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169777316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169777316006431697773166431697773160643169777316

GMDN Terms

TermDefinition
Stereotactic surgery system workstationA freestanding image processing device specifically designed to be networked with one or more stereotactic surgery systems. It typically does not contain the controls for the direct operation of the system, but rather is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the stereotactic system's operator console. It may be configured to provide the capability to further process, manipulate and/or view patient images and information collected from one or more systems.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
835233107
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

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