SilverHawkTM

GUDID 00821684074169

Mechanical atherectomy system catheter, peripheral

Primary Device ID	00821684074169
NIH Device Record Key	e14b230f-8efb-4d3b-b0fd-8e27e61830d3
Commercial Distribution Status	In Commercial Distribution
Brand Name	SilverHawkTM
Version Model Number	P4056
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

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	00821684074169 [Primary]

MCW	Catheter, peripheral, atherectomy

Steralize Prior To Use	true
Device Is Sterile	true

[00821684074169]

Ethylene Oxide

[00821684074169]

Ethylene Oxide

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