FDA.reportPublic FDA data

EnVisio System SmartSensor and SmartCal Disk

Primary DI
10851674008611
Brand
EnVisio System SmartSensor and SmartCal Disk
Company
Elucent Medical, Inc.
Model
EnVisio System SmartSensor and SmartCal Disk
Catalog number
SmartSensor
Device description
EnVisio System SmartSensor and SmartCal Disk
Published
2026-08-05
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
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183400000EnVisio Navigation SytemElucent Medical, Inc.2019-03-22NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851674008611PrimaryGS10
00851674008614Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167400861110851674008611
00851674008614008516740086148516740086140851674008614

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical tracking system spatial marker, external, powered, single-useAn electrically-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of an instrument and/or patient during a surgically-invasive procedure; the EM-tracking diagrams may be subsequently overlaid on radiological images for surgical navigation. Also referred to as a sensor, it is designed to be attached to a surgical instrument (e.g., electrosurgical handpiece) and produces a positional signal when exposed to a variable EM field, which can be detected and traced by the system. A disposable calibrator may be supplied with the marker. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
844-417-1700customerservice@elucent.com

Regulatory Flags#

DUNS number
079322481
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10851674008642SmartClipSMARTCLIPLT-YLW-5SMARTCLIPLT-YLW-52026-07-08
10851674008659SmartClipSMARTCLIPLT-YLW-7.5SMARTCLIPLT-YLW-7.52026-07-08
10851674008666SmartClipSMARTCLIPLT-YLW-10SMARTCLIPLT-YLW-102026-07-08
10851674008093SmartClipSMARTCLIP LITE, PINK, 5CMSMARTCLIPLT-PNK-52022-11-04
10851674008130SmartClipSMARTCLIP LITE, GREEN, 5CMSMARTCLIPLT-GRN-52020-04-13
10851674008147SmartClipSMARTCLIP LITE, PINK, 5CMSMARTCLIPLT-PNK-52020-04-13
10851674008154SmartClipSMARTCLIP LITE, PINK, 7.5CMSMARTCLIPLT-PNK-7.52020-04-13
10851674008161SmartClipSMARTCLIP LITE, PINK, 10CMSMARTCLIPLT-PNK-102020-04-13
10851674008178SmartClipSMARTCLIP LITE, GREEN, 7.5CMSMARTCLIPLT-GRN-7.52020-04-13
10851674008185SmartClipSMARTCLIP LITE, GREEN, 10CMSMARTCLIPLT-GRN-102020-04-13
10851674008192SmartClipSMARTCLIP LITE, PURPLE, 5CMSMARTCLIPLT-PURP-52020-04-13
10851674008208SmartClipSMARTCLIP LITE, PURPLE, 7.5CMSMARTCLIPLT-PRP-7.52020-04-13
10851674008215SmartClipSMARTCLIP LITE, PURPLE, 10CMSMARTCLIPLT-PURP-102020-04-13
10851674008253SmartClipSMARTCLIP LITE, PINK, 7.5CMSMARTCLIPLT-PNK-7.52022-11-04
10851674008260SmartClipSMARTCLIP LITE, PINK, 10CMSMARTCLIPLT-PNK-102022-11-04
10851674008277SmartClipSMARTCLIP LITE, GREEN, 5CMSMARTCLIPLT-GRN-52022-11-04
10851674008284SmartClipSMARTCLIP LITE, GREEN, 7.5CMSMARTCLIPLT-GRN-7.52022-11-04
10851674008291SmartClipSMARTCLIP LITE, GREEN, 10CMSMARTCLIPLT-GRN-102022-11-04
10851674008307SmartClipSMARTCLIP LITE, PURPLE, 5CMSMARTCLIPLT-PURP-52022-11-04
10851674008314SmartClipSMARTCLIP LITE, PURPLE, 7.5CMSMARTCLIPLT-PRP-7.52022-11-04

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