ZINGER® MARKER

GUDID 20643169452682

GDWR ZNGRMK300J ZINGERMK 5PK 300 J SIL

MEDTRONIC, INC.

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

• Primary Device ID: 20643169452682
• NIH Device Record Key: 75eccb8b-5555-48e0-8bac-a0117e15017c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZINGER® MARKER
• Version Model Number: ZNGRMK300J
• 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

Device Dimensions

• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169452688 [Primary]
GS1	20643169452682 [Package]; Contains: 00643169452688; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-23

On-Brand Devices [ZINGER® MARKER]

• 00643169452695: GDWR ZNGRMK180HS ZINGERMK 5PK 180 ST HY
• 20643169452682: GDWR ZNGRMK300J ZINGERMK 5PK 300 J SIL
• 20643169452675: GDWR ZNGRMK300S ZINGERMK 5PK 300 ST SIL
• 20643169452507: GDWR ZNGRMK180J ZINGERMK 5PK 180 J SIL
• 20643169452484: GDWR ZNGRMK300HJ ZINGERMK 5PK 300 J HY
• 20643169452477: GDWR ZNGRMK300HS ZINGERMK 5PK 300 ST HY
• 00643169452466: GDWR ZNGRMK180HJ ZINGERMK 5PK 180 J HY
• 20643169452491: GDWR ZNGRMK180S ZINGERMK 5PK 180 ST SIL
• 20763000569635: GDWR ZNGRMK180HS ZINGERMK 5PK 180 ST HY
• 20763000569628: GDWR ZNGRMK300J ZINGERMK 5PK 300 J SIL
• 20763000569611: GDWR ZNGRMK300S ZINGERMK 5PK 300 ST SIL
• 20763000569444: GDWR ZNGRMK180J ZINGERMK 5PK 180 J SIL
• 20763000569437: GDWR ZNGRMK180S ZINGERMK 5PK 180 ST SIL
• 20763000569420: GDWR ZNGRMK300HJ ZINGERMK 5PK 300 J HY
• 20763000569413: GDWR ZNGRMK300HS ZINGERMK 5PK 300 ST HY
• 20763000569406: GDWR ZNGRMK180HJ ZINGERMK 5PK 180 J HY