FDA.reportPublic FDA data

Valvulotome 23cm, blade 2mm, w/ball

Primary DI
04057034015322
Brand
Valvulotome 23cm, blade 2mm, w/ball
Company
Geister Medizintechnik GmbH
Model
03-7510
Catalog number
03-7510
Device description
Valvulotome 23cm, blade 2mm, w/ball
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGZVALVULOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057034015322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057034015322040570340153224057034015322

GMDN Terms#

Term, Definition table
TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013182304BoomerangAveera Medical Inc.MGZ2025-07-14
00860013182311BoomerangAveera Medical Inc.MGZ2025-07-14
00850041730134LimFlow VectorInari Medical, Inc.MGZ2024-04-12
00850041730028LimFlow VectorInari Medical, Inc.MGZ2023-06-26
00840663102297Eze-Sit Valvulotome Lemaitre Vascular, Inc.MGZ2022-06-30
H862TIVCNC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVCNC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVH40NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
00887482049938Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049945Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049952Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049969Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090282Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090299Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
M944AL103110Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-20
M944AL103010Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-19
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
00846159010978SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010985SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010992SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159031997SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159032000SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
H862TIVC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2016-08-31