Robinson

GUDID 00763000034276

PROSTHESIS 0342 ROBINSON MALL/OVAL 5.5MM

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00763000034276
• NIH Device Record Key: f298abfa-d719-4772-b433-ee9e40b0d0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robinson
• Version Model Number: 0342
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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

Device Dimensions

• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 5.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034276 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

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