Primary Device ID | 10846835022780 |
NIH Device Record Key | 7cab52bc-75a5-40d6-92ab-ccea0725539f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SOUNDSTAR CRYSTAL Ultrasound Catheter |
Version Model Number | 11510826 |
Catalog Number | 11510826 |
Company DUNS | 020163218 |
Company Name | Biosense Webster Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | true |
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)729-9010 |
RA-BWIUS-Complaints@its.jnj.com | |
Phone | +1(800)729-9010 |
RA-BWIUS-Complaints@its.jnj.com |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damage |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damage |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10846835022780 [Primary] |
OBJ | Catheter, ultrasound, intravascular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-04 |
Device Publish Date | 2024-06-26 |
10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter | 2024-07-04SOUNDSTAR CRYSTAL Ultrasound Catheter |
10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter | 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter |
10846835016796 - TX eco EXT Cable | 2023-10-12 TX eco EXT Cable |
10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 F-J Curve |
10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 D-F Curve |
10846835017427 - TX eco Cable | 2023-07-31 TX eco Cable Kit |
10846835017434 - TX eco Cable Dongle Spare Part | 2023-07-31 TX eco Cable Dongle Spare Part |
10846835020229 - LASSOSTAR Non-NAV -Circular navigation catheter | 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,20MM |
10846835020236 - LASSOSTAR Non-NAV -Circular navigation catheter | 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,15MM |