FDA.reportPublic FDA data

GEOFORM ANNULOPLASTY RING WITH HOLDER - MITRAL

Primary DI
00690103166538
Brand
GEOFORM ANNULOPLASTY RING WITH HOLDER - MITRAL
Company
Edwards Lifesciences LLC
Model
4200
Catalog number
4200M32
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103166538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103166538006901031665386901031665380690103166538

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57460691952770TRUWAVEPXMK1077PXMK10772026-03-20
57460691955887TRUWAVEPXMK1780PXMK17802026-03-20
00690103000382SWAN-GANZ TRUE SIZE123F6123F6P2026-03-16
50690103218287SWAN-GANZ VIP831F75831F75P2026-03-16
50690103218607SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
50690103218621SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
50690103218638SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL20A9631PL20A2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL23A9631PL23A2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL26A9631PL26A2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL29A9631PL29A2026-02-17
00690103019353AORTIC TRUE-SIZE OBTURATOR 19MM1161116119MM2026-02-13
00690103019360AORTIC TRUE-SIZE OBTURATOR 21MM1161116121MM2026-02-13
00690103019377AORTIC TRUE-SIZE OBTURATOR 23MM1161116123MM2026-02-13
00690103019384AORTIC TRUE-SIZE OBTURATOR 25MM1161116125MM2026-02-13
00690103019391AORTIC TRUE-SIZE OBTURATOR 27MM1161116127MM2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MM1161116129MM2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MM1161116131MM2026-02-13
00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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
00763000659264SimuForm™MEDTRONIC, INC.KRH2026-02-01