FDA.reportPublic FDA data

SmartClip

Primary DI
00851674008577
Brand
SmartClip
Company
Elucent Medical, Inc.
Model
SMARTCLIPLT-VLT-5
Catalog number
SMARTCLIPLT-VLT-5
Device description
Soft Tissue Marker and Delivery System - Violet, 5 cm (T-Lock)
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K180640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180640000SmartClip Soft Tissue MarkerElucent Medical, Inc.2018-06-04NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851674008574PrimaryGS10
00851674008577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167400857410851674008574
00851674008577008516740085778516740085770851674008577

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 radiographic film or digital 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079322481
Device count
10
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
true
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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