Robinson

GUDID 00681490017824

PROSTHESIS 0343 ROBINSON MALL/OVAL 6MM

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00681490017824
• NIH Device Record Key: e5e5b092-7d0e-4393-ba96-d88c435c423f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robinson
• Version Model Number: 0343
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490017824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885201

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

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: 2015-06-15

On-Brand Devices [Robinson]

• 00681490034449: PROSTHESIS 1133008 CUP PISTON .4X4.5 SST
• 00681490034432: PROSTHESIS 1133007 CUP PISTON .4X4.0 SST
• 00681490034425: PROSTHESIS 1133006 CUP PISTON .4X4.5 SST
• 00681490034418: PROSTHESIS 1133005 CUP PISTON .4X4.0 SST
• 00681490034401: PROSTHESIS 1133004 CUP PISTON .6X4.5 SST
• 00681490034395: PROSTHESIS 1133003 CUP PISTON .6X4.0 SST
• 00681490034388: PROSTHESIS 1133002 CUP PISTON .6X4.5 SST
• 00681490034371: PROSTHESIS 1133001 CUP PISTON .6X4.0 SST
• 00681490017824: PROSTHESIS 0343 ROBINSON MALL/OVAL 6MM
• 00681490017817: PROSTHESIS 0342 ROBINSON MALL/OVAL 5.5MM
• 00681490017800: PROSTHESIS 0341 ROBINSON MALL/OVAL 5MM
• 00681490017718: PROSTHESIS 0340 ROBINSON MALL/OVAL 4.5MM
• 00763000034283: PROSTHESIS 0343 ROBINSON MALL/OVAL 6MM
• 00763000034276: PROSTHESIS 0342 ROBINSON MALL/OVAL 5.5MM
• 00763000034269: PROSTHESIS 0341 ROBINSON MALL/OVAL 5MM
• 00763000034252: PROSTHESIS 0340 ROBINSON MALL/OVAL 4.5MM