Indigo™

GUDID 00643169579217

BUR 31132080 INDIGO RND FINE DMND 2.0MM

MEDTRONIC POWERED SURGICAL SOLUTIONS

Orthopaedic bur, reusable

• Primary Device ID: 00643169579217
• NIH Device Record Key: eff87dc2-0e02-42e6-bc3a-547caf410eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indigo™
• Version Model Number: 31132080
• Company DUNS: 098308849
• Company Name: MEDTRONIC POWERED SURGICAL SOLUTIONS
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169579217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111520

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00643169579217]

Moist Heat or Steam Sterilization

[00643169579217]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-04-08

On-Brand Devices [Indigo™]

• 00643169637948: BUR 31146063 INDIGO RND SST CUT 6.0MM
• 00643169637931: BUR 31147062 INDIGO RND SST CUT 7.0MM
• 00643169591226: BUR 31140584 INDIGO RND SST CUT 0.5MM
• 00643169591219: BUR 31141084 INDIGO RND SST CUT 1.0MM
• 00643169591189: BUR 31130684 INDIGO RND FINE DMND 0.6MM
• 00643169591172: BUR 31130884 INDIGO RND FINE DMND 0.8MM
• 00643169591165: BUR 31131084 INDIGO RND FINE DMND 1.0MM
• 00643169579316: BUR 31143079 INDIGO RND SST CUT 3.0MM
• 00643169579293: BUR 31141583 INDIGO RND SST CUT 1.5MM
• 00643169579286: BUR 31142080 INDIGO RND SST CUT 2.0MM
• 00643169579279: BUR 31142579 INDIGO RND SST CUT 2.5MM
• 00643169579231: BUR 31131283 INDIGO RND FINE DMND 1.2MM
• 00643169579224: BUR 31131583 INDIGO RND FINE DMND 1.5MM
• 00643169579217: BUR 31132080 INDIGO RND FINE DMND 2.0MM
• 00643169579200: BUR 31132579 INDIGO RND FINE DMND 2.5MM
• 00643169579194: BUR 31133079 INDIGO RND FINE DMND 3.0MM
• 00643169579187: BUR 31133576 INDIGO RND FINE DMND 3.5MM
• 00643169579170: BUR 31134076 INDIGO RND FINE DMND 4.0MM