FDA.reportPublic FDA data

Lunderquist

Primary DI
10827002492285
Brand
Lunderquist
Company
William Cook Europe ApS
Model
G49228
Catalog number
TSMG-35-180-7-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

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
10827002492285PackageGS15In Commercial Distribution
00827002492288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700249228510827002492285
00827002492288008270024922888270024922880827002492288

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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