FDA.reportPublic FDA data

CG FUTURE®

Primary DI
00613994521026
Brand
CG FUTURE®
Company
MEDTRONIC, INC.
Model
638RL34
Device description
RING 638RL34 CG FUTURE 10L
Published
2015-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRHRING, ANNULOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRHRing, AnnuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061127000CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638RMedtronic Vascular2006-05-23KRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994521026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994521026006139945210266139945210260613994521026

GMDN Terms#

Term, Definition table
TermDefinition
Mitral annuloplasty ringA sterile circular band intended to be implanted in the heart for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter34Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Heat
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Store 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000659301SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659318SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659325SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659332SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659349SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659356SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659363SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659370SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659387SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659394SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659400SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659417SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659424SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659431SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659448SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659455SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659462SimuPlus™MEDTRONIC, INC.KRH2026-02-02
00763000659509Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659516Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659523Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659530Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659547Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659554Tri-Ad™MEDTRONIC, INC.KRH2026-02-02
00763000659561Tri-Ad™MEDTRONIC, INC.KRH2026-02-01
00763000659202SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659219SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659226SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659233SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659240SimuForm™MEDTRONIC, INC.KRH2026-02-01
00763000659257SimuForm™MEDTRONIC, INC.KRH2026-02-01