FDA.report

Lunderquist

Primary DI
10827002467290
Brand
Lunderquist
Company
William Cook Europe ApS
Model
G46729
Catalog number
TSMG-35-180-4-LES
Device description
Lunderquist, Extra Stiff Wire Guide
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQXWIRE, GUIDE, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10827002467290PackageGS15In Commercial Distribution
00827002467293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700246729010827002467290
00827002467293008270024672938270024672930827002467293

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
305302119
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10827002601595Zenith AlphaG60159ZTA2-D-28-160-W2024-12-18
10827002601656Zenith AlphaG60165ZTA2-D-30-160-W2024-12-18
10827002601717Zenith AlphaG60171ZTA2-D-32-160-W2024-12-18
10827002601748Zenith AlphaG60174ZTA2-D-32-229-W2024-12-18
10827002601779Zenith AlphaG60177ZTA2-D-34-142-W2024-12-18
10827002601809Zenith AlphaG60180ZTA2-D-34-190-W2024-12-18
10827002601830Zenith AlphaG60183ZTA2-D-36-142-W2024-12-18
10827002601861Zenith AlphaG60186ZTA2-D-36-190-W2024-12-18
10827002601892Zenith AlphaG60189ZTA2-D-38-147-W2024-12-18
10827002601922Zenith AlphaG60192ZTA2-D-38-197-W2024-12-18
10827002601953Zenith AlphaG60195ZTA2-D-40-147-W2024-12-18
10827002601984Zenith AlphaG60198ZTA2-D-40-197-W2024-12-18
10827002602011Zenith AlphaG60201ZTA2-D-42-152-W2024-12-18
10827002602042Zenith AlphaG60204ZTA2-D-42-204-W2024-12-18
10827002602073Zenith AlphaG60207ZTA2-D-44-157-W2024-12-18
10827002602103Zenith AlphaG60210ZTA2-D-44-211-W2024-12-18
10827002602127Zenith AlphaG60212ZTA2-D-46-211-W2024-12-18
10827002602158Zenith AlphaG60215ZTA2-D-46-157-W2024-12-18
10827002599816Zenith AlphaG59981ZTA2-P-30-132-W2024-12-04
10827002599847Zenith AlphaG59984ZTA2-P-30-155-W2024-12-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10816349013536GuideRightLake Region MedicalDQX2026-03-24
10816349013543GuideRightLake Region MedicalDQX2026-03-24
10816349013550GuideRightLake Region MedicalDQX2026-03-24
10816349013567GuideRightLake Region MedicalDQX2026-03-24
10816349013574GuideRightLake Region MedicalDQX2026-03-24
10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
10816349013604GuideRightLake Region MedicalDQX2026-03-24
10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
16936733736408ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736415ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736644ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736651ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736668ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
06936733736678ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736965ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736996ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737009ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737085ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27