Tri-Ad™

GUDID 00643169301085

RING TRI-AD ADAMS 900SFC30 30MM

MEDTRONIC, INC.

Mitral/tricuspid annuloplasty ring

• Primary Device ID: 00643169301085
• NIH Device Record Key: 7f699af1-337d-4def-bf2a-a82e79c27b08
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tri-Ad™
• Version Model Number: 900SFC30
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• Serial Number: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter
• Lumen/Inner Diameter: 30 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169301085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093903

FDA Product Code

• KRH: RING, ANNULOPLASTY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-04
• Device Publish Date: 2015-06-19

On-Brand Devices [Tri-Ad™]

• 00643169301108: RING TRI-AD ADAMS 900SFC34 34MM
• 00643169301085: RING TRI-AD ADAMS 900SFC30 30MM
• 00643169195394: RING 900SFC36 TRI-AD ADAMS
• 00643169195387: RING 900SFC34 TRI-AD ADAMS
• 00643169195370: RING 900SFC32 TRI-AD ADAMS
• 00643169195363: RING 900SFC30 TRI-AD ADAMS
• 00643169195356: RING 900SFC28 TRI-AD ADAMS
• 00643169195349: RING 900SFC26 TRI-AD ADAMS
• 00763000102357: BAND 900SFC236 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102340: BAND 900SFC234 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102333: BAND 900SFC232 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102326: BAND 900SFC230 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102319: BAND 900SFC228 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102302: BAND 900SFC226 TRI-AD2.0 ADAMS TRICUSPID
• 00763000102296: 7900PS TRI-AD 2.0 ADAMS SIZER SET