Primary Device ID | 15414734400135 |
NIH Device Record Key | 69570536-6023-4229-b703-ab6911a5c126 |
Commercial Distribution Discontinuation | 2018-03-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | SJM™ |
Version Model Number | 1115 |
Catalog Number | 1115 |
Company DUNS | 021675699 |
Company Name | ADVANCED NEUROMODULATION SYSTEMS, 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 | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |