PROFILE 3D™

GUDID 00613994749390

RING 680R28 PROFILE 3D 26L INSERT

MEDTRONIC, INC.

Mitral annuloplasty ring
Primary Device ID00613994749390
NIH Device Record Key9a7edda2-5aac-4a08-9f8e-dd3866b61321
Commercial Distribution Discontinuation2017-07-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePROFILE 3D™
Version Model Number680R28
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 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 *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 *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 *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 *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 *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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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 Away From Heat
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
GS100613994749390 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-06-18

On-Brand Devices [PROFILE 3D™]

00613994749437RING 680R36 PROFILE 3D 26L INSERT
00613994749420RING 680R34 PROFILE 3D 26L INSERT
00613994749413RING 680R32 PROFILE 3D 26L INSERT
00613994749406RING 680R30 PROFILE 3D 26L INSERT
00613994749390RING 680R28 PROFILE 3D 26L INSERT
00613994749383RING 680R26 PROFILE 3D 26L INSERT
00613994749376RING 680R24 PROFILE 3D 26L INSERT
00613994410344RING 680R26 PROFILE 3D 26L
00613994410337RING 680R32 PROFILE 3D 26L
00613994410313RING 680R28 PROFILE 3D 26L
00613994410306RING 680R30 PROFILE 3D 26L
00613994410283RING 680R38 PROFILE 3D 26L
00763000318505SIZER SET 7680S PROFILE 3D 26L CE

Trademark Results [PROFILE 3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFILE 3D
PROFILE 3D
77107095 3473054 Live/Registered
Medtronic, Inc.
2007-02-14

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