SmartClip SMARTCLIP-PINK-10
GUDID 10851674008086
Soft Tissue Marker and Delivery System - PINK (Revised Frequency)
ELUCENT MEDICAL, INC.
Imaging lesion localization marker, implantable| Primary Device ID | 10851674008086 |
| NIH Device Record Key | e9e11b23-84d6-485c-bcb8-7c5b0bdec25e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartClip |
| Version Model Number | SMARTCLIP-PINK-10 |
| Catalog Number | SMARTCLIP-PINK-10 |
| Company DUNS | 079322481 |
| Company Name | ELUCENT MEDICAL, INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851674008089 [Unit of Use] |
| GS1 | 10851674008086 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180640
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-04 |
| Device Publish Date | 2020-01-27 |
On-Brand Devices [SmartClip]
| 00851674008027 | Soft Tissue Marker and Delivery System |
| 00851674008010 | Soft Tissue Marker and Delivery System |
| 00851674008003 | Soft Tissue Marker and Delivery System |
| 10851674008024 | Soft Tissue Marker and Delivery System - PURPLE |
| 10851674008017 | Soft Tissue Marker and Delivery System - GREEN |
| 10851674008000 | Soft Tissue Marker and Delivery System - PINK |
| 10851674008086 | Soft Tissue Marker and Delivery System - PINK (Revised Frequency) |
| 00851674008218 | Soft tissue marker and delivery system, Purple, 10cm |
| 00851674008201 | Soft tissue marker and delivery system, Purple, 7.5cm |
| 00851674008195 | Soft tissue marker and delivery system, Purple, 5cm |
| 00851674008188 | Soft tissue marker and delivery system - Green, 10cm |
| 00851674008171 | Soft tissue marker and delivery system - Green, 7.5cm |
| 00851674008164 | Soft tissue marker and delivery system - Pink, 10cm |
| 00851674008157 | Soft tissue marker and delivery system - Pink, 7.5cm |
| 00851674008140 | Soft tissue marker and delivery system - Pink, 5cm |
| 00851674008133 | Soft tissue marker and delivery system - Green, 5cm |
| 00851674008324 | Soft tissue marker and delivery system, Purple, 10cm |
| 00851674008317 | Soft tissue marker and delivery system, Purple, 7.5cm |
| 00851674008300 | Soft tissue marker and delivery system, Purple, 5cm |
| 00851674008294 | Soft tissue marker and delivery system - Green, 10cm |
| 00851674008287 | Soft tissue marker and delivery system - Green, 7.5cm |
| 00851674008270 | Soft tissue marker and delivery system - Green, 5cm |
| 00851674008263 | Soft tissue marker and delivery system - Pink, 10cm |
| 00851674008256 | Soft tissue marker and delivery system - Pink, 7.5cm |
| 00851674008096 | Soft tissue marker and delivery system - Pink, 5cm |
Trademark Results [SmartClip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTCLIP 98275141 not registered Live/Pending |
Package, Inc. 2023-11-17 |
 SMARTCLIP 97497224 not registered Live/Pending |
smartclip Europe GmbH 2022-07-11 |
 SMARTCLIP 97336086 not registered Live/Pending |
Smartclip Europe GmbH 2022-03-29 |
 SMARTCLIP 88546817 not registered Live/Pending |
TRACKINGPACKING, INC. 2019-07-29 |
 SMARTCLIP 88266467 not registered Dead/Abandoned |
Chanbonpin, James B. 2019-01-18 |
 SMARTCLIP 87560625 not registered Dead/Abandoned |
i-BLADES, Inc. 2017-08-08 |
 SMARTCLIP 87230179 not registered Live/Pending |
Elucent Medical, Inc. 2016-11-08 |
 SMARTCLIP 79011112 3411780 Dead/Cancelled |
Sirona Dental Systems GmbH 2004-01-12 |
 SMARTCLIP 78338435 2984134 Live/Registered |
3M Company 2003-12-09 |
 SMARTCLIP 77739140 4110590 Live/Registered |
Smartclip AG 2009-05-18 |
 SMARTCLIP 77739131 4110589 Live/Registered |
Smartclip AG 2009-05-18 |
 SMARTCLIP 77244074 3531975 Dead/Cancelled |
Inventor's Workshop, LLC 2007-08-01 |
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