FDA.reportPublic FDA data

Valvulotome 25cm, blade 2mm, w/ball

Primary DI
04057034015308
Brand
Valvulotome 25cm, blade 2mm, w/ball
Company
Geister Medizintechnik GmbH
Model
03-7505
Catalog number
03-7505
Device description
Valvulotome 25cm, 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
OTC
false
Sterile
false
Single use
false

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
04057034015308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057034015308040570340153084057034015308

GMDN Terms#

Term, Definition table
TermDefinition
Valvulotome, reusableA 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.

Contacts#

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

Regulatory Flags#

DUNS number
343548848
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057034015322Valvulotome 23cm, blade 2mm, w/ball03-751003-75102016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD491118070Surgical DirectSurgical Direct, Inc.MGZ2026-10-22
00190776433796MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433802MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433819MillenniumAvalign Technologies, Inc.MGZ2026-10-08
B382SD4911930Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
B382SD491118030Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
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 ValvulotomeLemaitre 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
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21