FDA.reportPublic FDA data

SmartClip

Primary DI
10851674008130
Brand
SmartClip
Company
Elucent Medical, Inc.
Model
SMARTCLIP LITE, GREEN, 5CM
Catalog number
SMARTCLIPLT-GRN-5
Device description
Soft tissue marker and delivery system - Green, 5cm
Published
2020-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
10851674008130PrimaryGS10
00851674008133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167400813010851674008130
00851674008133008516740081338516740081330851674008133

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

Contacts#

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

Regulatory Flags#

DUNS number
079322481
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851674008560SmartClip Lite - Eval KitSMARTCLIPLT-EVALKITSMARTCLIPLT-EVALKIT2026-02-25
10851674008574SmartClipSMARTCLIPLT-VLT-5 SMARTCLIPLT-VLT-5 2026-02-16
10851674008581SmartClipSMARTCLIPLT-VLT-7.5SMARTCLIPLT-VLT-7.52026-02-16
10851674008598SmartClipSMARTCLIPLT-VLT-10 SMARTCLIPLT-VLT-10 2026-02-16
10851674008604SmartClip SecureSMARTCLIP-SEC-VLTSMARTCLIP-SEC-VLT2026-02-16
00851674008577SmartClipSMARTCLIPLT-VLT-5 SMARTCLIPLT-VLT-5 2026-02-16
00851674008584SmartClipSMARTCLIPLT-VLT-7.5SMARTCLIPLT-VLT-7.52026-02-16
00851674008591SmartClipSMARTCLIPLT-VLT-10 SMARTCLIPLT-VLT-10 2026-02-16
00851674008607SmartClip SecureSMARTCLIP-SEC-VLTSMARTCLIP-SEC-VLT2026-02-16
00851674008034EnVisioENVISIO-SYSENVISIO-SYS2019-04-15
00851674008454SmartSensorSMARTSENSOR2025-03-31
00851674008553EnVisio SystemENVISIO-SYS2025-02-04
10851674008468SmartClipSMARTCLIPLT-PINK-5SMARTCLIPLT-PINK-52025-10-01
10851674008475SmartClipSMARTCLIPLT-PNK-7.5SMARTCLIPLT-PNK-7.52025-10-01
10851674008482SmartClipSMARTCLIPLT-PINK-10SMARTCLIPLT-PINK-102025-10-01
10851674008499SmartClipSMARTCLIPLT-PURP-5SMARTCLIPLT-PURP-52025-10-01
10851674008505SmartClipSMARTCLIPLT-PURP-7.5SMARTCLIPLT-PURP-7.52025-10-01
10851674008512SmartClipSMARTCLIPLT-PURP-10SMARTCLIPLT-PURP-102025-10-01
10851674008529SmartClipSMARTCLIPLT-GRN-5SMARTCLIPLT-GRN-52025-10-01
10851674008536SmartClipSMARTCLIPLT-GRN-7.5SMARTCLIPLT-GRN-7.52025-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22