SecurMark SMARK-EVIVA-2S-10
GUDID 05420045503604
Hologic, Inc.
Imaging lesion localization marker, implantable| Primary Device ID | 05420045503604 |
| NIH Device Record Key | ab229186-6d50-4085-95f2-0fae1263f071 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SecurMark |
| Version Model Number | SMARK-EVIVA-2S-10 |
| Catalog Number | SMARK-EVIVA-2S-10 |
| 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 | 05420045503604 [Primary] |
| GS1 | 15420045503601 [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 |
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
Radiation Sterilization
[05420045503604]
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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