FDA.reportPublic FDA data

Strange

Primary DI
00827002091085
Brand
Strange
Company
COOK INCORPORATED
Model
G09108
Catalog number
C-CSRC-7.5D-40-STRANGE
Device description
Cook Strange Bile Duct Stone Exploration Set
Published
2020-03-16
Public version status
Update
Distribution status
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
LQRDISLODGER, STONE, BILIARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQRDislodger, Stone, BiliaryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173687000Strange Bile Duct Stone Exploration SetCook Incorporated2017-12-15LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002091085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002091085008270020910858270020910850827002091085

GMDN Terms#

Term, Definition table
TermDefinition
Biliary stone retrieval basketA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate biliary stones for the treatment of conditions such as cholelithiasis (i.e., presence of calculi in the bile duct or gallbladder). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is typically used in a procedure such as an endoscopic retrograde cholangiopancreatography (ERCP) or a laparoscopic cholecystectomy. 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
042823948
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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664900741NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900758NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900796NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900802NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900819NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664900826NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901465NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664901472NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903568NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903575NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903582NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903599NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903605NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903629NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664903797NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907597NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907603NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907610NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664907627NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664910672NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911310NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911327NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911556NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911563NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664911570NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912171NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912188NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912195NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912201NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03
06959664912218NAHangzhou AGS MedTech Co., Ltd.LQR2026-08-03