Biliary Stone Basket

Primary DI
B032500240
Brand
Biliary Stone Basket
Company
SACRED HEART MEDICAL,INC.
Model
50024
Catalog number
50024
Published
2017-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K925559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925559000BILIARY STONE DISLODGERAnnex Medical, Inc.1992-12-17LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B032500240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an endoscopic procedure [e.g., endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832763002
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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B0325305200Hercules5305205305202016-11-15
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B0325541200Halo5541205541202016-11-15
B03255616006-Wire Halo5561605561602016-11-15

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Primary DI, Brand, Company table
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