Cragg McNamaraTM

GUDID 00847536006737

INF CATH 41042-01 CRAGG-MCNAMARA V03

Micro Therapeutics, Inc.

Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 00847536006737
• NIH Device Record Key: 5c837b94-7afc-424b-bcf3-300aa04f1e7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cragg McNamaraTM
• Version Model Number: 41042-01
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536006737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940634

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

[00847536006737]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-04-01

On-Brand Devices [Cragg McNamaraTM]

• 00847536007093: INF CATH 41060-01 CRAGG-MCNAMARA V03
• 00847536007086: INF CATH 41059-01 CRAGG-MCNAMARA V04
• 00847536007079: INF CATH 41059-01 CRAGG-MCNAMARA V03
• 00847536007055: INF CATH 41058-01 CRAGG-MCNAMARA V03
• 00847536007048: INF CATH 41057-01 CRAGG-MCNAMARA V04
• 00847536007031: INF CATH 41057-01 CRAGG-MCNAMARA V03
• 00847536007017: INF CATH 41056-01 CRAGG-MCNAMARA V03
• 00847536006997: INF CATH 41055-01 CRAGG-MCNAMARA V03
• 00847536006973: INF CATH 41054-01 CRAGG-MCNAMARA V03
• 00847536006966: INF CATH 41053-01 CRAGG-MCNAMARA V04
• 00847536006959: INF CATH 41053-01 CRAGG-MCNAMARA V03
• 00847536006935: INF CATH 41052-01 CRAGG-MCNAMARA V03
• 00847536006911: INF CATH 41051-01 CRAGG-MCNAMARA V03
• 00847536006898: INF CATH 41050-01 CRAGG-MCNAMARA V03
• 00847536006874: INF CATH 41049-01 CRAGG-MCNAMARA V03
• 00847536006850: INF CATH 41048-01 CRAGG-MCNAMARA V03
• 00847536006836: INF CATH 41047-01 CRAGG-MCNAMARA V03
• 00847536006812: INF CATH 41046-01 CRAGG-MCNAMARA V03
• 00847536006799: INF CATH 41045-01 CRAGG-MCNAMARA V03
• 00847536006775: INF CATH 41044-01 CRAGG-MCNAMARA V03
• 00847536006751: INF CATH 41043-01 CRAGG-MCNAMARA V03
• 00847536006737: INF CATH 41042-01 CRAGG-MCNAMARA V03
• 00847536006713: INF CATH 41041-01 CRAGG-MCNAMARA V03
• 00847536006690: INF CATH 41040-01 CRAGG-MCNAMARA V03
• 00847536006676: INF CATH 41039-01 CRAGG-MCNAMARA V03
• 00847536006652: INF CATH 41038-01 CRAGG-MCNAMARA V03
• 00847536006638: INF CATH 41037-01 CRAGG-MCNAMARA V03
• 00847536006614: INF CATH 41036-01 CRAGG-MCNAMARA V03
• 00847536006591: INF CATH 41035-01 CRAGG-MCNAMARA V03
• 00847536006553: INF CATH 41033-01 CRAGG-MCNAMARA V03
• 00847536006539: INF CATH 41032-01 CRAGG-MCNAMARA V03
• 00836462000018: INF CATH 41031-01 CRAGG-MCNAMARA