ATHERECTOMY FG02550 CUTTERDRIVER Medical Device Identification

GUDID 00763000402433

ATHERECTOMY FG02550 CUTTERDRIVER

MEDTRONIC, INC.

Mechanical atherectomy system catheter, peripheral

Primary Device ID	00763000402433
NIH Device Record Key	e963461b-908e-42fc-8b82-a0c950fc85b0
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000402433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212027

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	1
Public Version Date	2021-10-04
Device Publish Date	2021-09-26

Devices Manufactured by MEDTRONIC, INC.

00199150008643 - NA	2025-05-12 CUSTOM PACK BB5X98R22 UCLA PED
20199150011609 - NA	2025-05-12 CUSTOM PACK 12P80R 20PK 1/2 X 3/8 CONN L
00199150011612 - NA	2025-05-12 CUSTOM PACK BB11U88R7 PEDI ADAPTATI
00199150011629 - NA	2025-05-12 CUSTOM PACK BB3F83R10 HEAD PK
00199150014361 - NA	2025-05-12 CUSTOM PACK BB7X79R6 CP PRIME
20199150014594 - NA	2025-05-12 CUSTOM PACK BB8Q15R2 10PK 1/2 VENOUS
00199150014606 - NA	2025-05-12 CUSTOM PACK BB10M30R1 OXY EXCHANGE
00199150014613 - NA	2025-05-12 CUSTOM PACK BB10Y54R5 ECC PED 1/4