Primary Device ID | 00821684074121 |
NIH Device Record Key | 6e1391bb-7397-4548-800f-dbac9d470cd9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SilverHawkTM |
Version Model Number | P4052 |
Company DUNS | 968903703 |
Company Name | Covidien LP |
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 | 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)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Special Storage Condition, Specify | Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
Special Storage Condition, Specify | Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00821684074121 [Primary] |
MCW | Catheter, peripheral, atherectomy |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00821684074121]
Ethylene Oxide
[00821684074121]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-08-27 |
00821684074169 | ATHERECTOMY P4056 SILVERHAWK ATK V03 |
00821684074145 | ATHERECTOMY P4055 SILVERHAWK ATK V03 |
00821684074121 | ATHERECTOMY P4052 SILVERHAWK ATK V03 |
00821684074107 | ATHERECTOMY P4044 SILVERHAWK BTK V03 |
00821684074084 | ATHERECTOMY P4034 SILVERHAWK BTK V03 |
00821684074060 | ATHERECTOMY P4033 SILVERHAWK BTK V03 |
00821684074046 | ATHERECTOMY P4030 SILVERHAWK BTK V03 |
00821684074039 | ATHERECTOMY P4028 SILVERHAWK BTK V03 |