SecurMark SMARK-E13-SS1
GUDID 05420045503918
Hologic, Inc.
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable| Primary Device ID | 05420045503918 |
| NIH Device Record Key | f5f7dc97-b7f0-428a-b47a-ab6d0f4d4500 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SecurMark |
| Version Model Number | SMARK-E13-SS1 |
| Catalog Number | SMARK-E13-SS1 |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05420045503918 [Primary] |
| GS1 | 15420045503915 [Package] Package: BOX [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062528
FDA Product Code
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
[05420045503918]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-04 |
On-Brand Devices [SecurMark]
| 05420045503963 | SMARK-E10-SS3 |
| 05420045503956 | SMARK-E10-SS2 |
| 05420045503949 | SMARK-E10-SS1 |
| 05420045503932 | SMARK-E13-SS3 |
| 05420045503925 | SMARK-E13-SS2 |
| 05420045503918 | SMARK-E13-SS1 |
| 15420045503908 | SMARK-U-SS3 |
| 15420045503892 | SMARK-U-SS2 |
| 15420045503885 | SMARK-U-SS1 |
| 05420045503628 | SMARK-EVIVA-2S-13 |
| 05420045503611 | SMARK-EVIVA-13 |
| 05420045503604 | SMARK-EVIVA-2S-10 |
| 05420045503598 | SMARK-EVIVA-10 |
| 05420045503406 | SMARK-CELERO-2S |
| 05420045503390 | SMARK-CELERO |
Trademark Results [SecurMark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SECURMARK 87977302 not registered Dead/Abandoned |
Securmark Scandinavia AS 2017-06-15 |
 SECURMARK 87491378 not registered Live/Pending |
Securmark Scandinavia AS 2017-06-15 |
 SECURMARK 77218165 3603330 Live/Registered |
HOLOGIC, INC. 2007-06-28 |
 SECURMARK 74157671 1726333 Dead/Cancelled |
SECURMARK AG 1991-04-16 |
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