FAXITRON WEDGE 120-807600
GUDID 15420045516656
Surgical specimen container for taking orthogonal view of the specimen under x-ray
Hologic, Inc.
Tissue specimen x-ray system IVD| Primary Device ID | 15420045516656 |
| NIH Device Record Key | ba907cb2-e7c3-4424-b847-2f42f6f29fda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FAXITRON WEDGE |
| Version Model Number | 120-807600 |
| Catalog Number | 120-807600 |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045516656 [Primary] |
FDA Product Code
| MWP | Cabinet, x-ray system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
Devices Manufactured by Hologic, Inc.
| 15420045517059 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test |
| 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 |
| 15420045517073 - Aptima® | 2024-12-27 Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificatio |
| 15420045517080 - Aptima® | 2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat |
| 15420045506411 - ATEC | 2024-10-24 |
| 15420045506428 - ATEC | 2024-10-24 |
| 15420045516144 - Fluent Pro Procedure Kit | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
| 15420045516113 - Fluent Pro Waste Bag | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
Trademark Results [FAXITRON WEDGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FAXITRON WEDGE 85962451 4509676 Live/Registered |
FAXITRON BIOPTICS, LLC 2013-06-18 |
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