FDA.reportPublic FDA data

Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm

Primary DI
03701311501077
Brand
Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm
Company
ECENTIAL ROBOTICS
Model
A01029
Published
2023-09-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221028000SURGIVISIO DeviceEcential Robotics2022-07-06OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701311501077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311501077037013115010773701311501077

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, single-useA slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33458005520service@ecential-robotics.com

Regulatory Flags#

DUNS number
261610964
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
037013115004453DSRW SoftwareL000162023-03-01
03701311500995Broach Set SPX1A010212023-09-04
037013115009713D Offset Imaging Set SPX1A010382023-09-04
03701311501015Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mmA010202023-09-04
03701311501039Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mmA010282023-09-04
03701311501053Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mmA010192023-09-04
03701311501121SURGIVISIO DEVICEI010012023-09-04
03701311500322CoBotI000192023-03-01
03701311500407SURGIVISIOI000012023-03-01
03701311501442Op.n Core Power CordI010152025-11-04
03701311501459Op.n Core ethernet cableI010162025-11-04
03701311501466Op.n Core HDMI cableI010182025-11-04
03701311500032Broach Set SPX1A000212023-03-01
03701311501497Op.n ChoiceSpine AppL600182025-05-15
037013115000183D Imaging Set SPX1A000182023-03-01
037013115003913D Offset Imaging Set SPX1A000382023-03-01
03701311501275Op.n CameraI000262025-03-20
03701311500865Op.n Tracker AA000632025-03-20
03701311500872Op.n Tracker BA000642025-03-20
03701311500889Op.n Tracker CA000652025-03-20

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