FDA.reportPublic FDA data

Ruler, Suture, for Chordae, acc. Mohr 3-60mm 35cm

Primary DI
04057034013564
Brand
Ruler, Suture, for Chordae, acc. Mohr 3-60mm 35cm
Company
Geister Medizintechnik GmbH
Model
03-5409
Catalog number
03-5409
Device description
Ruler, Suture, for Chordae, acc. Mohr 3-60mm 35cm ValveGate™
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTISIZER, HEART-VALVE, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTISizer, Heart-Valve, ProsthesisCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057034013564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057034013564040570340135644057034013564

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve annulus sizer, reusableA hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497461966240info@geister.com

Regulatory Flags#

DUNS number
343548848
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejector40-3218C140-3218C12026-05-26
04057034047958DeBakey Vascular Dilator 19cm 6.0mm21-0207.JR21-0207.JR2023-10-11
04057034047965Dilator, Vascular, acc. DeBakey 19cm 6.0mm21-0207.SI21-0207.SI2023-10-11
04057034292327Dilator, Vascular, acc. DeBakey 19cm 6.0mm #Custom-made product#21-0207.NI21-0207.NI2023-10-11
04057034047484Garret Garrett Vessel Probe Holders 21cm21-015621-01562023-09-29
04057034047491Dilator, Vascular, acc. Garrett, set 35cm (12 sizes 0.5-9.0mm)21-016021-01602023-09-29
04057034047507Dilator, Vascular, acc. Garrett 35cm 0.5mm21-016121-01612023-09-29
04057034047514Dilator, Vascular, acc. Garrett 35cm 1.0mm21-016221-01622023-09-29
04057034047521Dilator, Vascular, acc. Garrett 35cm 1.5mm21-016321-01632023-09-29
04057034047538Dilator, Vascular, acc. Garrett 35cm 2.0mm21-016421-01642023-09-29
04057034047545Dilator, Vascular, acc. Garrett 35cm 2.5mm21-016521-01652023-09-29
04057034047552Dilator, Vascular, acc. Garrett 35cm 3.0mm21-016621-01662023-09-29
04057034047569Dilator, Vascular, acc. Garrett 35cm 3.5mm21-016721-01672023-09-29
04057034047576Dilator, Vascular, acc. Garrett 35cm 4.0mm21-016821-01682023-09-29
04057034047583Dilator, Vascular, acc. Garrett 35cm 4.5mm21-016921-01692023-09-29
04057034047590Dilator, Vascular, acc. Garrett 35cm 5.0mm21-017021-01702023-09-29
04057034047606Dilator, Vascular, acc. Garrett 35cm 7.0mm21-017121-01712023-09-29
04057034047613Dilator, Vascular, acc. Garrett 35cm 9.0mm21-017221-01722023-09-29
04057034047651Dilator, Vascular, acc. DeBakey 19cm 0.5mm21-019921-01992023-09-29
04057034047668Dilator, Vascular, acc. DeBakey 19cm 0.5mm21-0199.SI21-0199.SI2023-09-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103019728HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019735HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
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00690103019766HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019773HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
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00690103019797HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019803HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019810HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019827HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019834HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019841HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019858HEART VALVE ACCESSORYEdwards Lifesciences LLCDTI2026-04-06
00690103019889KONECT AVC SIZER 19MMEdwards Lifesciences LLCDTI2026-04-06
00690103019896KONECT AVC SIZER 21MMEdwards Lifesciences LLCDTI2026-04-06
00690103019902KONECT AVC SIZER 23MMEdwards Lifesciences LLCDTI2026-04-06
00690103019919KONECT AVC SIZER 25MMEdwards Lifesciences LLCDTI2026-04-06
00690103019926KONECT AVC SIZER 27MMEdwards Lifesciences LLCDTI2026-04-06
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