FDA.reportPublic FDA data

Lunderquist

Primary DI
00827002204836
Brand
Lunderquist
Company
William Cook Europe ApS
Model
G20483
Catalog number
TSCMG-35-90-5-3-LES1
Device description
Lunderquist, Extra Stiff Wire Guide
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
DQXWIRE, GUIDE, CATHETER

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002204836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002204836008270022048368270022048360827002204836

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002599109Zenith AlphaG59910ZTA2-P-46-179-W2024-12-03
00827002599123Zenith AlphaG59912ZTA2-P-46-233-W2024-12-03
00827002599154Zenith AlphaG59915ZTA2-P-40-117-W2024-12-03
00827002599185Zenith AlphaG59918ZTA2-P-40-142-W2024-12-03
00827002599215Zenith AlphaG59921ZTA2-P-40-167-W2024-12-03
00827002599239Zenith AlphaG59923ZTA2-P-40-217-W2024-12-03
00827002599260Zenith AlphaG59926ZTA2-P-42-121-W2024-12-03
00827002599321Zenith AlphaG59932ZTA2-P-42-173-W2024-12-03
00827002599352Zenith AlphaG59935ZTA2-P-42-225-W2024-12-03
00827002599383Zenith AlphaG59938ZTA2-P-44-125-W2024-12-03
00827002599413Zenith AlphaG59941ZTA2-P-44-152-W2024-12-03
00827002599444Zenith AlphaG59944ZTA2-P-44-179-W2024-12-03
00827002599475Zenith AlphaG59947ZTA2-P-44-233-W2024-12-03
00827002599505Zenith AlphaG59950ZTA2-P-46-125-W2024-12-03
00827002599567Zenith AlphaG59956ZTA2-P-24-105-W2024-12-03
00827002599581Zenith AlphaG59958ZTA2-P-24-127-W2024-12-03
00827002599604Zenith AlphaG59960ZTA2-P-26-105-W2024-12-03
00827002599659Zenith AlphaG59965ZTA2-P-28-109-W2024-12-03
00827002599697Zenith AlphaG59969ZTA2-P-28-132-W2024-12-03
00827002599727Zenith AlphaG59972ZTA2-P-28-155-W2024-12-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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