FDA.reportPublic FDA data

TUNNELERTUNNELER

Primary DI
50884908039912
Brand
TUNNELERTUNNELER
Company
Medical Components, Inc.
Model
RTT
Device description
RAULERSON FOOTBALLRAULERSON FOOT TROCAR SETTROCAR SET
Published
2017-07-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50884908039912PackageGS15Not in Commercial Distribution
00884908039917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490803991250884908039912
00884908039917008849080399178849080399170884908039917

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00884908144697N/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
00884908031119TUNNELERMedical Components, Inc.MZY2017-05-18