| Primary Device ID | 15420045515260 |
| NIH Device Record Key | 0b5f71a2-4663-46ac-8fc6-8e51e54b745f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acessa ProVu System |
| Version Model Number | 7400 |
| Catalog Number | 7400 |
| Company DUNS | 018925968 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 | |
| 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 |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045515260 [Primary] |
| HFG | COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
[15420045515260]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-23 |
| Device Publish Date | 2024-09-13 |
| 15420045515284 | 5200 |
| 15420045515314 | MS-06-0171 |
| 15420045515307 | 7100 |
| 15420045515253 | 3000 |
| 15420045515246 | 7300 |
| 15420045515291 | The Acessa ProVu Transducer Sensor |
| 15420045515277 | The Acessa ProVu Pad Cable |
| 15420045515260 | The Acessa ProVu Handpiece Cable |