FDA.reportPublic FDA data

Dilator, Vascular, acc. Garrett 35cm 0.5mm

Primary DI
04057034047507
Brand
Dilator, Vascular, acc. Garrett 35cm 0.5mm
Company
Geister Medizintechnik GmbH
Model
21-0161
Catalog number
21-0161
Device description
Dilator, Vascular, acc. Garrett 35cm 0.5mm
Published
2023-09-29
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
DWPDILATOR, VESSEL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWPDilator, Vessel, SurgicalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057034047507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057034047507040570340475074057034047507

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, reusableA hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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
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
04057034047682Dilator, Vascular, acc. DeBakey 19cm 1.25mm21-0200.2521-0200.252023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123359Sarns Myocardial DilatorSONTEC INSTRUMENTS, INC.DWP2026-04-23
00846159035926SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWP2025-11-13
14026704927873PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927880PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927897PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
14026704927903PILLINGTELEFLEX INCORPORATEDDWP2025-09-30
00887482160893Symmetry GarrettASPEN SURGICAL PRODUCTS, INC.DWP2024-08-14
04058749118780NAFehling Instruments GmbH & Co. KGDWP2024-01-08
04058749118797NAFehling Instruments GmbH & Co. KGDWP2024-01-08
07070554104670Medistim Interconnect CableMedistim ASADWP2020-10-30
07070554104700Medistim Interconnect cableMedistim ASADWP2020-10-30
07070554104717Medistim Interconnect cableMedistim ASADWP2020-10-30
07070554104793Medistim Interconnect CableMedistim ASADWP2020-10-30
34026704652618PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652625PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652632PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652649PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652656PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652670PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652687PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704655961PILLINGTELEFLEX INCORPORATEDDWP2020-09-16
34026704652663PILLINGTELEFLEX INCORPORATEDDWP2020-03-23
00192896010703GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-29
00192896005563GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010680GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010697GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010710TUNNELERSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896010727TUBBS MITRAL VALVE DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-24
00192896005570GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21
00192896005587GARRETT VASCULAR DILATORSONTEC INSTRUMENTS, INC.DWP2018-08-21