Apex 544310

GUDID B0325443100

2.4 Fr, 90 cm, NiTi Flat Wire Stone Basket

SACRED HEART MEDICAL,INC.

Urinary stone retrieval basket, single-use

• Primary Device ID: B0325443100
• NIH Device Record Key: 9e37834a-293f-410f-b40c-7992e8010db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex
• Version Model Number: 544310
• Catalog Number: 544310
• Company DUNS: 832763002
• Company Name: SACRED HEART MEDICAL,INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	B0325443100 [Primary]

FDA Product Code

• FFL: Dislodger, Stone, Basket, Ureteral, Metal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-15

On-Brand Devices [Apex]

• B0325443200: 2.4 Fr, 120 cm, NiTi Flat Wire Stone Basket
• B0325443100: 2.4 Fr, 90 cm, NiTi Flat Wire Stone Basket