FDA.reportPublic FDA data

N/A

Primary DI
00884908144697
Brand
N/A
Company
Medical Components, Inc.
Model
DMRACC5STUNSL
Device description
"1-0.054"" BARBED TUNNELER FOR 5F PRO-LINE®"
Published
2019-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZYGraft, Vascular, Stainless Steel Tunneler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZYGraft, Vascular, Stainless Steel TunnelerCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908144692PackageGS15In Commercial Distribution
00884908144697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814469250884908144692
00884908144697008849081446978849081446970884908144697

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
2152564201complaints@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884908189674MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641501DMC6415012026-08-08
00884908189681MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641502DMC6415022026-08-08
00884908189698MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641503DMC6415032026-08-08
00884908189704MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641504DMC6415042026-08-08
00884908189711MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641505DMC6415052026-08-08
00884908189728MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641506DMC6415062026-08-08
00884908166330T-3 Triple Lumen CTMC013505MC0135052026-07-24
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDTHD155165DTHD1551652025-11-27
00884908092752T-3 Triple Lumen CTMC0135022015-10-23
00884908092769T-3 TRIPLE LUMEN CTMC0135032016-02-23
00884908016901GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREG130NG130N2018-10-06
00884908105254GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900202017-11-28
00884908105278GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900402017-12-02
00884908145090GALT GUIDEWIREGALT GUIDEWIREDMR190040DMR1900402019-09-04
00884908136630DUO-FLOW® SIDE X SIDEAS0914151AS09141512026-05-13
00884908136647DUO-FLOW® SIDE X SIDEAS0914201AS09142012026-05-13
00884908136654DUO-FLOW® SIDE X SIDEAS0914241AS09142412026-05-13
00884908136661DUO-FLOW® SIDE X SIDEAC0914151AC09141512026-05-13
00884908136678DUO-FLOW® SIDE X SIDEAC0914201AC09142012026-05-13
00884908136685DUO-FLOW® SIDE X SIDEAC0914241AC09142412026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD49129230Surgical DirectSurgical Direct, Inc.MZY2026-08-03
00613745003009KMRtrack Monitoring marker KMR013 (48) GenBioMZY2025-12-26
00884908089783N/AN/AMedical Components, Inc.MZY2019-09-07
50884908089788N/AN/AMedical Components, Inc.MZY2019-09-07
00884908144680N/AMedical Components, Inc.MZY2019-08-28
00884908144703N/AMedical Components, Inc.MZY2019-08-28
00884908144710N/AMedical Components, Inc.MZY2019-08-28
00884908144727N/AMedical Components, Inc.MZY2019-08-28
00884908144741N/AMedical Components, Inc.MZY2019-08-28
50884908144685N/AMedical Components, Inc.MZY2019-08-28
50884908144692N/AMedical Components, Inc.MZY2019-08-28
50884908144708N/AMedical Components, Inc.MZY2019-08-28
50884908144715N/AMedical Components, Inc.MZY2019-08-28
50884908144722N/AMedical Components, Inc.MZY2019-08-28
50884908144746N/AMedical Components, Inc.MZY2019-08-28
00884908142044TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142051TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142068TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142075TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142049TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142056TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142063TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142070TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908145656N/AN/AMedical Components, Inc.MZY2019-08-10
00884908145663N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145651N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145668N/AN/AMedical Components, Inc.MZY2019-08-10
00884908039917TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
50884908039912TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
00884908031119TUNNELERMedical Components, Inc.MZY2017-05-18