ATHERECTOMY FG02550 CUTTERDRIVER UNI Medical Device Identification

GUDID 00643169968547

ATHERECTOMY FG02550 CUTTERDRIVER UNI

MEDTRONIC, INC.

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Primary Device ID	00643169968547
NIH Device Record Key	262d101b-5dc8-4b85-8da3-b332eae5ad76
Commercial Distribution Status	In Commercial Distribution
Version Model Number	FG02550
Company DUNS	006261481
Company Name	MEDTRONIC, 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	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

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169968547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170191

FDA Product Code

MCW	Catheter, peripheral, atherectomy

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-07-06
Device Publish Date	2018-04-28

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