SIMPLICI-T®

GUDID 00763000411367

BAND 670100 SIMPLICI-T ANNULOPLASTY 10L

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
Primary Device ID00763000411367
NIH Device Record Key23157428-f3d2-4659-b4f4-47ba2d7ec940
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIMPLICI-T®
Version Model Number670100
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Dimensions

Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter
Lumen/Inner Diameter100 Millimeter

Operating and Storage Conditions

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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away From Heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]
GS100763000411367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY
KRHRING, ANNULOPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-06

On-Brand Devices [SIMPLICI-T®]

00613994759276BND 670100 SIMPLICI-T ANLPLSTY 10L MEX
00763000411367BAND 670100 SIMPLICI-T ANNULOPLASTY 10L

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