Primary Device ID | 15420045510203 |
NIH Device Record Key | 82b9b195-f7af-4ef7-a4a5-be04db84f290 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MyoSure Rod Lens Hysteroscope |
Version Model Number | 40-200 |
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 | 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 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045510203 [Primary] |
HIH | HYSTEROSCOPE (AND ACCESSORIES) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
[15420045510203]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2018-10-03 |
15420045511422 - Panther Fusion® | 2024-06-18 Cytomegalovirus (CMV) Primers ASR. |
15420045511439 - Panther Fusion® | 2024-06-18 Cytomegalovirus (CMV) Probe ASR. |
15420045511484 - Panther Fusion® | 2024-06-18 Varicella zoster virus (VZV) Primers ASR. |
15420045511491 - Panther Fusion® | 2024-06-18 Varicella zoster virus (VZV) Probe ASR. |
15420045512115 - Panther Fusion® | 2024-06-18 Hologic CMV Plasmid Control. |
15420045512146 - Panther Fusion® | 2024-06-18 Hologic VZV Plasmid Control. |
15420045513877 - DIGITAL DIAGNOSTICS SYSTEM | 2024-06-17 The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system. |
15420045513884 - DIGITAL DIAGNOSTICS SYSTEM | 2024-06-17 Computer to operate the Genius™ Digital Imager. |