ATS SIMULUS®

GUDID 00643169300903

BAND SIM SRB 800SC28 SEMI-RIGID 28MM

MEDTRONIC, INC.

Mitral annuloplasty ring
Primary Device ID00643169300903
NIH Device Record Key987c51a1-c04a-4992-afe7-34b334dfb463
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameATS SIMULUS®
Version Model Number800SC28
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 Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter
Lumen/Inner Diameter28 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169300903 [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 Date2018-12-11
Device Publish Date2015-06-18

On-Brand Devices [ATS SIMULUS®]

00643169301290RING SIM FR 700FF35 FLEXIBLE 35MM
00643169301283RING SIM FR 700FF33 FLEXIBLE 33MM
00643169301276RING SIM FR 700FF31 FLEXIBLE 31MM
00643169301269RING SIM FR 700FF29 FLEXIBLE 29MM
00643169301245RING SIM FR 700FF25 FLEXIBLE 25MM
00643169301238RING SIM FR 700FF23 FLEXIBLE 23MM
00643169301221BAND SIM FB 700FC39 FLEXIBLE 39MM
00643169301214BAND SIM FB 700FC37 FLEXIBLE 37MM
00643169301207BAND SIM FB 700FC35 FLEXIBLE 35MM
00643169301191BAND SIM FB 700FC33 FLEXIBLE 33MM
00643169301184BAND SIM FB 700FC31 FLEXIBLE 31MM
00643169301177BAND SIM FB 700FC29 FLEXIBLE 29MM
00643169301160BAND SIM FB 700FC27 FLEXIBLE 27MM
00643169301153BAND SIM FB 700FC25 FLEXIBLE 25MM
00643169301146BAND SIM FB 700FC23 FLEXIBLE 23MM
00643169301047RING SIM SR 800SR38 SEMI-RIGID 38MM
00643169301030RING SIM SR 800SR36 SEMI-RIGID 36MM
00643169301009RING SIM SR 800SR30 SEMI-RIGID 30MM
00643169300996RING SIM SR 800SR28 SEMI-RIGID 28MM
00643169300934BAND SIM SRB 800SC34 SEMI-RIGID 34MM
00643169300927BAND SIM SRB 800SC32 SEMI-RIGID 32MM
00643169300910BAND SIM SRB 800SC30 SEMI-RIGID 30MM
00643169300903BAND SIM SRB 800SC28 SEMI-RIGID 28MM
00643169300897BAND SIM SRB 800SC26 SEMI-RIGID 26MM
00643169300880BAND SIM SRB 800SC24 SEMI-RIGID 24MM
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