FDA.reportPublic FDA data

CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G

Primary DI
50884908028039
Brand
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G
Company
Medical Components, Inc.
Model
MC150J
Catalog number
MC150J
Device description
0.035" (0.90MM) X 150CM0.035" (0 J/FLEX GUIDEWIREJ/FLEX GUIDEWIRE
Published
2018-10-24
Public version status
New
Distribution status
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
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884908028035PackageGS110In Commercial Distribution
50884908028039PackageGS14In Commercial Distribution
00884908028034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088490802803530884908028035
5088490802803950884908028039
00884908028034008849080280348849080280340884908028034

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use 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
false
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
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
00884908140798BREEZE® SECUREMENTBL0512BL05122022-02-26
00884908140804BREEZE® SECUREMENTBL1218BL12182022-02-26
00884908186697DIGNITY®MRDP80ALNMRDP80ALN2026-04-23
00884908186703DIGNITY®MRDP80ALSMRDP80ALS2026-04-23
00884908186710DIGNITY®MRDP80AMNMRDP80AMN2026-04-23
00884908186727DIGNITY®MRDP80AMSMRDP80AMS2026-04-23
00884908186734DIGNITY®MRDP80ASNMRDP80ASN2026-04-23
00884908186741DIGNITY®MRDP80AXSMRDP80AXS2026-04-23
00884908186758DIGNITY®MRDP80PLNMRDP80PLN2026-04-23
00884908186765DIGNITY®MRDP80PMNMRDP80PMN2026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
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08498840011874VYGONVygon CorporationDQX2019-04-08
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08498840011904VYGONVygon CorporationDQX2019-04-05
08498840011928VYGONVygon CorporationDQX2019-04-05
08714729327141Starter™ GuidewireLAKE REGION MEDICAL LIMITEDDQX2016-11-10