| Primary Device ID | 05420045503864 |
| NIH Device Record Key | fbebb005-dcfc-49e3-aaf8-55b65f3ac7a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SecurMark for ATEC |
| Version Model Number | SMARK-A1309-SS1 |
| Catalog Number | SMARK-A1309-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 |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05420045503864 [Primary] |
| GS1 | 15420045503861 [Package] Package: BOX [10 Units] In Commercial Distribution |
| NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
[05420045503864]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-29 |
| 05420045503871 | SMARK-A1309-SS2 |
| 05420045503864 | SMARK-A1309-SS1 |
| 05420045503857 | SMARK-A1312-SS2 |
| 05420045503840 | SMARK-A1312-SS1 |
| 05420045503833 | SMARK-A3609-SS3 |
| 05420045503826 | SMARK-A3609-SS2 |
| 05420045503819 | SMARK-A3609-SS1 |
| 05420045503482 | SMARK-ATEC-2S-36-12 |
| 05420045503475 | SMARK-ATEC-36-12 |
| 05420045503468 | SMARK-ATEC-2S-36-09 |
| 05420045503451 | SMARK-ATEC-36-09 |
| 05420045503444 | SMARK-ATEC-2S-13-12 |
| 05420045503437 | SMARK-ATEC-13-12 |
| 05420045503420 | SMARK-ATEC-2S-13-09 |
| 05420045503413 | SMARK-ATEC-13-09 |