ATS Tri-Ad®

GUDID 00643169301078

RING TRI-AD ADAMS 900SFC28 28MM

MEDTRONIC, INC.

Mitral/tricuspid annuloplasty ring

• Primary Device ID: 00643169301078
• NIH Device Record Key: f3480b5c-61c8-4ac7-b715-124ba78a801f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATS Tri-Ad®
• Version Model Number: 900SFC28
• 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
• 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
• 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: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter
• Lumen/Inner Diameter: 28 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product carton in a room temperate, dry place to protect the product and minimize contamination potential.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169301078 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-22

On-Brand Devices [ATS Tri-Ad®]

• 00643169301252: RING SIM FR 700FF27 FLEXIBLE 27MM
• 00643169301092: RING TRI-AD ADAMS 900SFC32 32MM
• 00643169301078: RING TRI-AD ADAMS 900SFC28 28MM
• 00643169301061: RING TRI-AD ADAMS 900SFC26 26MM
• 00643169301054: RING SIM SR 800SR40 SEMI-RIGID 40MM
• 00643169301023: RING SIM SR 800SR34 SEMI-RIGID 34MM
• 00643169301016: RING SIM SR 800SR32 SEMI-RIGID 32MM
• 00643169300989: RING SIM SR 800SR26 SEMI-RIGID 26MM
• 00643169300972: RING SIM SR 800SR24 SEMI-RIGID 24MM