FDA.reportPublic FDA data

EnVisio

Primary DI
10085167400822
Brand
EnVisio
Company
Elucent Medical, Inc.
Model
ENVISIO-HUD2
Catalog number
ENVISIO-HUD2
Device description
EnVisio Navigation System Heads Up Display Version 2
Published
2020-12-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
10085167400822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008516740082210085167400822

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Contacts#

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

Regulatory Flags#

DUNS number
079322481
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
10851674008611EnVisio System SmartSensor and SmartCal DiskEnVisio System SmartSensor and SmartCal DiskSmartSensor2026-08-05
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

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