FDA.reportPublic FDA data

SmartClip Lite - Eval Kit

Primary DI
00851674008560
Brand
SmartClip Lite - Eval Kit
Company
Elucent Medical, Inc.
Model
SMARTCLIPLT-EVALKIT
Catalog number
SMARTCLIPLT-EVALKIT
Device description
SmartClip Lite- Evaluation Kit
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00851674008560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851674008560008516740085608516740085600851674008560

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
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10851674008543SmartClipSMARTCLIPLT-GRN-10SMARTCLIPLT-GRN-102025-10-01