FDA.reportPublic FDA data

SmartClip

Primary DI
10851674008178
Brand
SmartClip
Company
Elucent Medical, Inc.
Model
SMARTCLIP LITE, GREEN, 7.5CM
Catalog number
SMARTCLIPLT-GRN-7.5
Device description
Soft tissue marker and delivery system - Green, 7.5cm
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
10851674008178PrimaryGS10
00851674008171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085167400817810851674008178
00851674008171008516740081718516740081710851674008171

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
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
15060391210459Magseed ProENDOMAGNETICS LTDNEU2024-08-15
15060391210466Magseed ProENDOMAGNETICS LTDNEU2024-08-15
15060391210350SentimagENDOMAGNETICS LTDNEU2024-02-09
15060391210008Sentimag Base UnitENDOMAGNETICS LTDNEU2023-06-20
15060391210015Sentimag SMP02 Probe AssemblyENDOMAGNETICS LTDNEU2023-06-20
15060391210039Sentimag SMC02 Probe Test PhantomENDOMAGNETICS LTDNEU2023-06-20
25060391210012Sentimag SMH02 Probe HolderENDOMAGNETICS LTDNEU2023-06-20
10851674008093SmartClipElucent Medical, Inc.NEU2022-11-04