Silverstein

GUDID 00763000034757

PROSTHESIS 1112120 H/A INCUS-STAPES CONN

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00763000034757
• NIH Device Record Key: f0f5b8e8-8eca-4156-9521-3ef12ca107a8
• 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 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

• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.1 Millimeter
• Height: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034757 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

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