Silverstein

GUDID 00681490033428

PROSTHESIS 1112120 H/A INCUS-STAPES CONN

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial Ossicular prosthesis, partial

• Primary Device ID: 00681490033428
• NIH Device Record Key: a2c552e0-e3b9-4372-8baa-7ba5cf4ed4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverstein
• Version Model Number: 1112120
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490033428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810707

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: 2015-06-19

On-Brand Devices [Silverstein]

• 20681490040819: PACKING 1428010 6PK REG STRIPS POLYEST
• 20681490040802: PACKING 1428005 6PK LONG STRIPS POLYEST
• 20681490040765: PACKING 1425020 6PK REG STRIPS FLPL
• 20681490040758: PACKING 1425015 6PK LONG STRIPS FLPL
• 00681490033428: PROSTHESIS 1112120 H/A INCUS-STAPES CONN
• 20681490030049: VENT TUBE 1028070 5PK SPAT 1.14X7MM SIL
• 20681490030032: VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL
• 20763000038995: VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL
• 00763000034757: PROSTHESIS 1112120 H/A INCUS-STAPES CONN