FDA.reportPublic FDA data

NA

Primary DI
03664539003405
Brand
NA
Company
DIXI MEDICAL
Model
WIRE GUIDE
Catalog number
ACS-SG1S-5
Device description
SET OF 5 WIRE GUIDES, ACCESSORY OF MICRODEEP MICRO-MACRO DEPTH ELECTRODE
Published
2022-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664539003405PrimaryGS10
03664539003481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664539003405036645390034053664539003405
03664539003481036645390034813664539003481

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Contacts#

Phone, Email table
PhoneEmail
+33381889890info@diximedical.com

Regulatory Flags#

DUNS number
268009609
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664539003641NAANCHOR BOLTACS-125SMS-102022-10-10
03664539003658NAANCHOR BOLTACS-130SMS-102022-10-10
03664539003665NAANCHOR BOLTACS-135SMS-102022-10-10
03664539003672NAANCHOR BOLTACS-040SMS-102022-10-10
03664539003689NAANCHOR BOLTACS-140SMS-102022-10-10
03664539003900NAINSTRUMENT GUIDEACS-789/82R2024-04-03
03664539003917NAINSTRUMENT GUIDEACS-789/120R2024-04-03
03664539003559NACONNECTION CABLECBL-06/1202022-07-06
03664539003566NACONNECTION CABLECBL-06/1502022-07-06
03664539003573NACONNECTION CABLECBL-06/1802022-07-06
03664539003580NACONNECTION CABLECBL-06/3002022-07-06
03664539003603NACONNECTION CABLECBL-09/1202022-07-06
03664539003610NACONNECTION CABLECBL-09/1502022-07-06
03664539003627NACONNECTION CABLECBL-09/1802022-07-06
03664539003634NACONNECTION CABLECBL-09/3002022-07-06
03664539003535NADRILL AND STOPKIP-ACS-515B2022-04-04
03664539000015NAMICRODEEP DEPTH ELECTRODED08-05AM2017-12-14
03664539000039NAMICRODEEP DEPTH ELECTRODED08-08AM2017-12-14
03664539000053NAMICRODEEP DEPTH ELECTRODED08-10AM2017-12-14
03664539000077NAMICRODEEP DEPTH ELECTRODED08-12AM2017-12-14

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