Biliary Stone Basket 50024

GUDID B032500240

SACRED HEART MEDICAL,INC.

Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use Biliary/urinary stone retrieval basket, single-use

• Primary Device ID: B032500240
• NIH Device Record Key: c767140f-fb4c-42bf-8ffd-4e1784d8b147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biliary Stone Basket
• Version Model Number: 50024
• Catalog Number: 50024
• Company DUNS: 832763002
• Company Name: SACRED HEART MEDICAL,INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B032500240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925559

FDA Product Code

• LQR: Dislodger, Stone, Biliary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-05-26

Devices Manufactured by SACRED HEART MEDICAL,INC.

• B032500240 - Biliary Stone Basket: 2020-05-06
• B032500240 - Biliary Stone Basket: 2020-05-06
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• B0325305200 - Hercules: 2018-03-29 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket
• B0325305250 - Hercules: 2018-03-29 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket with Filiform Tip
• B0325443100 - Apex: 2018-03-29 2.4 Fr, 90 cm, NiTi Flat Wire Stone Basket
• B0325443200 - Apex: 2018-03-29 2.4 Fr, 120 cm, NiTi Flat Wire Stone Basket
• B0325503100 - Vantage: 2018-03-29 2.4 Fr, 90 cm, NiTi Tipless Stone Basket
• B0325503200 - Vantage: 2018-03-29 2.4 Fr, 120 cm, NiTi Tipless Stone Basket