| Primary Device ID | 15420045506855 |
| NIH Device Record Key | 2a39032c-8d30-400a-83da-9da50908c754 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC PEARL |
| Version Model Number | ATEC PEARL |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045506855 [Primary] |
| KNW | INSTRUMENT, BIOPSY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-30 |
| 15420045506411 - ATEC | 2024-10-24 |
| 15420045506428 - ATEC | 2024-10-24 |
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