SimuPlus™

GUDID 00763000271138

RING 7700FR38 SIMUPLUS FLEX 38MM US

MEDTRONIC, INC.

Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery
Primary Device ID00763000271138
NIH Device Record Key133030fa-e586-4528-a228-4b11098c83d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimuPlus™
Version Model Number7700FR38
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
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
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
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 Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter
Lumen/Inner Diameter38 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 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 AgencyDevice ID
GS100763000271138 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-07
Device Publish Date2020-07-30

On-Brand Devices [SimuPlus™]

00763000271565ACCY 7700FS SIMUPLUS R/B SIZERS SIL
00763000271558ACCY 7700PS SIMUPLUS R/B SIZERS PS
00763000271152RING 7700FR42 SIMUPLUS FLEX 42MM US
00763000271145RING 7700FR40 SIMUPLUS FLEX 40MM US
00763000271138RING 7700FR38 SIMUPLUS FLEX 38MM US
00763000271121RING 7700FR36 SIMUPLUS FLEX 36MM US
00763000271114RING 7700FR34 SIMUPLUS FLEX 34MM US
00763000271107RING 7700FR32 SIMUPLUS FLEX 32MM US
00763000271091RING 7700FR30 SIMUPLUS FLEX 30MM US
00763000271084RING 7700FR28 SIMUPLUS FLEX 28MM US
00763000271077RING 7700FR26 SIMUPLUS FLEX 26MM US
00763000271060BAND 7700FB42 SIMUPLUS FLEX 42MM US
00763000271053BAND 7700FB40 SIMUPLUS FLEX 40MM US
00763000271046BAND 7700FB38 SIMUPLUS FLEX 38MM US
00763000271039BAND 7700FB36 SIMUPLUS FLEX 36MM US
00763000271022BAND 7700FB34 SIMUPLUS FLEX 34MM US
00763000271015BAND 7700FB32 SIMUPLUS FLEX 32MM US
00763000271008BAND 7700FB30 SIMUPLUS FLEX 30MM US
00763000270995BAND 7700FB28 SIMUPLUS FLEX 28MM US
00763000270988BAND 7700FB26 SIMUPLUS FLEX 26MM US
00763000271459Ring 7700FR42 SimuPlus Flex 42mm GLB
00763000271442Ring 7700FR40 SimuPlus Flex 40mm GLB
00763000271435Ring 7700FR38 SimuPlus Flex 38mm GLB
00763000271428Ring 7700FR36 SimuPlus Flex 36mm GLB
00763000271411Ring 7700FR34 SimuPlus Flex 34mm GLB
00763000271404Ring 7700FR32 SimuPlus Flex 32mm GLB
00763000271398Ring 7700FR30 SimuPlus Flex 30mm GLB
00763000271381Ring 7700FR28 SimuPlus Flex 28mm GLB
00763000271374Ring 7700FR26 SimuPlus Flex 26mm GLB
00763000271367Band 7700FB42 SimuPlus Flex 42mm GLB
00763000271350Band 7700FB40 SimuPlus Flex 40mm GLB
00763000271343Band 7700FB38 SimuPlus Flex 38mm GLB
00763000271336Band 7700FB36 SimuPlus Flex 36mm GLB
00763000271329Band 7700FB34 SimuPlus Flex 34mm GLB
00763000271312Band 7700FB32 SimuPlus Flex 32mm GLB
00763000271305Band 7700FB30 SimuPlus Flex 30mm GLB
00763000271299Band 7700FB28 SimuPlus Flex 28mm GLB
00763000271282Band 7700FB26 SimuPlus Flex 26mm GLB
00763000414290ACCY 7700FS SIMUPLUS R/B SIZERS SIL GLB
00763000414283ACCY 7700PS SIMUPLUS R/B SIZERS PS GLB

Trademark Results [SimuPlus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMUPLUS
SIMUPLUS
88375466 not registered Live/Pending
Medtronic, Inc
2019-04-08

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