COUGAR® LS

GUDID 20763000570051

GDWR CGRLS300J COUGARLS 5PK 300 J SIL

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 20763000570051
• NIH Device Record Key: cea8ff7f-9c72-4154-9080-a0cde738eaa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COUGAR® LS
• Version Model Number: CGRLS300J
• 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

Device Dimensions

• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000570057 [Primary]
GS1	20763000570051 [Package]; Contains: 00763000570057; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140695

FDA Product Code

• DQX: Wire, guide, catheter

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: 2022-02-14
• Device Publish Date: 2022-02-06

On-Brand Devices [COUGAR® LS]

• 20643169453313: GDWR CGRLS190HS COUGARLS 5PK 190 ST HY
• 20643169453283: GDWR LVCLS190S COUGRLS CRM 5PK 190 ST HY
• 20643169453276: GDWR LVCLS190J COUGARLS CRM 5PK 190 J HY
• 20643169452897: GDWR CGRLS190HJ COUGARLS 5PK 190 J HY
• 00643169452886: GDWR CGRLS190J COUGARLS 5PK 190 J SIL
• 00643169452879: GDWR CGRLS190S COUGARLS 5PK 190 ST SIL
• 20643169452866: GDWR CGRLS300HJ COUGARLS 5PK 300 J HY
• 20643169452859: GDWR CGRLS300HS COUGARLS 5PK 300 ST HY
• 20643169452842: GDWR CGRLS300J COUGARLS 5PK 300 J SIL
• 00643169452831: GDWR CGRLS300S COUGARLS 5PK 300 ST SIL
• 20763000570129: GDWR CGRLS190HS COUGARLS 5PK 190 ST HY
• 20763000570105: GDWR CGRLS190HJ COUGARLS 5PK 190 J HY
• 20763000570099: GDWR CGRLS190J COUGARLS 5PK 190 J SIL
• 20763000570082: GDWR CGRLS190S COUGARLS 5PK 190 ST SIL
• 20763000570075: GDWR CGRLS300HJ COUGARLS 5PK 300 J HY
• 20763000570068: GDWR CGRLS300HS COUGARLS 5PK 300 ST HY
• 20763000570051: GDWR CGRLS300J COUGARLS 5PK 300 J SIL
• 20763000570044: GDWR CGRLS300S COUGARLS 5PK 300 ST SIL