DxTerity™ TRA

GUDID 20763000016641

CATH U6ULTRA35 DXT 6F 5PK 100CM UL35

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20763000016641
• NIH Device Record Key: e1b3f868-e5f6-4032-ae3c-76a23d36edb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTerity™ TRA
• Version Model Number: U6ULTRA35
• 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

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000016647 [Primary]
GS1	20763000016641 [Package]; Contains: 00763000016647; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161287

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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: 2018-05-11

On-Brand Devices [DxTerity™ TRA]

• 20643169739141: CATH U6TRACTSHA DXT 6F 5PK 110CM TRACT
• 20643169739134: CATH U5TRACTSHA DXT 5F 5PK 110CM TRACT
• 20643169739110: CATH U6TRACTSH DXT 6F 5PK 100CM TRACT
• 20643169739103: CATH U5TRACTSH DXT 5F 5PK 100CM TRACT
• 20643169739080: CATH U6TRACT DXT 6F 5PK 100CM TRACT
• 20643169739073: CATH U5TRACT DXT 5F 5PK 100CM TRACT
• 20643169739059: CATH U6TRACKSHA DXT 6F 5PK 110CM TRACK
• 20643169739042: CATH U5TRACKSHA DXT 5F 5PK 110CM TRACK
• 20643169739028: CATH U6TRACKSH DXT 6F 5PK 100CM TRACK
• 20643169739011: CATH U5TRACKSH DXT 5F 5PK 100CM TRACK
• 20643169738991: CATH U6TRACK DXT 6F 5PK 100CM TRACK
• 20643169738984: CATH U5TRACK DXT 5F 5PK 100CM TRACK
• 20643169738960: CATH U6TRAN45SHA DXT 6F 5PK 110CM TRN45
• 20643169738953: CATH U5TRAN45SHA DXT 5F 5PK 110CM TRN45
• 20643169738939: CATH U6TRAN45SH DXT 6F 5PK 100CM TRN45
• 20643169738922: CATH U5TRAN45SH DXT 5F 5PK 100CM TRN45
• 20643169738908: CATH U6TRAN45 DXT 6F 5PK 100CM TRN45
• 20643169738892: CATH U5TRAN45 DXT 5F 5PK 100CM TRN45
• 20643169738878: CATH U6TRAN40SHA DXT 6F 5PK 110CM TRN40
• 20643169738861: CATH U5TRAN40SHA DXT 5F 5PK 110CM TRN40
• 20643169738847: CATH U6TRAN40SH DXT 6F 5PK 100CM TRN40
• 20643169738830: CATH U5TRAN40SH DXT 5F 5PK 100CM TRN40
• 20643169738816: CATH U6TRAN40 DXT 6F 5PK 100CM TRN40
• 20643169738809: CATH U5TRAN40 DXT 5F 5PK 100CM TRN40
• 20643169738786: CATH U6TRAN35SHA DXT 6F 5PK 110CM TRN35
• 20643169738779: CATH U5TRAN35SHA DXT 5F 5PK 110CM TRN35
• 20643169738755: CATH U6TRAN35SH DXT 6F 5PK 100CM TRN35
• 20643169738748: CATH U5TRAN35SH DXT 5F 5PK 100CM TRN35
• 20643169738724: CATH U6TRAN35 DXT 6F 5PK 100CM TRN35
• 20643169738717: CATH U5TRAN35 DXT 5F 5PK 100CM TRN35
• 20643169738694: CATH U6TRAP45SHA DXT 6F 5PK 110CM TRP45
• 20643169738687: CATH U5TRAP45SHA DXT 5F 5PK 110CM TRP45
• 20643169738663: CATH U6TRAP45SH DXT 6F 5PK 100CM TRP45
• 20643169738656: CATH U5TRAP45SH DXT 5F 5PK 100CM TRP45
• 20643169738632: CATH U6TRAP45 DXT 6F 5PK 100CM TRP45
• 20643169738625: CATH U5TRAP45 DXT 5F 5PK 100CM TRP45
• 20643169738601: CATH U6TRAP40SHA DXT 6F 5PK 110CM TRP40
• 20643169738595: CATH U5TRAP40SHA DXT 5F 5PK 110CM TRP40
• 20643169738571: CATH U6TRAP40SH DXT 6F 5PK 100CM TRP40
• 20643169738564: CATH U5TRAP40SH DXT 5F 5PK 100CM TRP40
• 20643169738540: CATH U6TRAP40 DXT 6F 5PK 100CM TRP40
• 20643169738533: CATH U5TRAP40 DXT 5F 5PK 100CM TRP40
• 20643169738519: CATH U6TRAP35SHA DXT 6F 5PK 110CM TRP35
• 20643169738502: CATH U5TRAP35SHA DXT 5F 5PK 110CM TRP35
• 20643169738489: CATH U6TRAP35SH DXT 6F 5PK 100CM TRP35
• 20643169738472: CATH U5TRAP35SH DXT 5F 5PK 100CM TRP35
• 20643169738458: CATH U6TRAP35 DXT 6F 5PK 100CM TRP35
• 20643169738441: CATH U5TRAP35 DXT 5F 5PK 100CM TRP35
• 20763000016887: CATH U6ULTRA45SHA DXT 6F 5PK 110CM UL45
• 20763000016870: CATH U5ULTRA45SHA DXT 5F 5PK 110CM UL45