| Primary Device ID | 15420045504875 |
| NIH Device Record Key | 3fe88b6c-36f1-41e1-98ca-d92298f86506 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATEC 0914-12MR |
| Version Model Number | ATEC 0914-12MR |
| Catalog Number | ATEC 0914-12MR |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045504875 [Primary] |
| GS1 | 25420045504872 [Package] Package: BOX [5 Units] In Commercial Distribution |
| GS1 | 35420045504879 [Package] Package: BOX [5 Units] In Commercial Distribution |
| KNW | INSTRUMENT, BIOPSY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045504875]
Radiation Sterilization
[15420045504875]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-26 |
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| 15420045517066 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te |
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