ATS Tri-Ad®

GUDID 00643169301252

RING SIM FR 700FF27 FLEXIBLE 27MM

MEDTRONIC, INC.

Mitral/tricuspid annuloplasty ring
Primary Device ID00643169301252
NIH Device Record Key25d8e365-82db-447a-af10-8d5945f05293
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameATS Tri-Ad®
Version Model Number700FF27
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter
Lumen/Inner Diameter27 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169301252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRHRING, ANNULOPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-07
Device Publish Date2015-09-22

On-Brand Devices [ATS Tri-Ad®]

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

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