Acucise® Endopyelotomy System

GUDID 10607915111660

Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE

APPLIED MEDICAL RESOURCES CORPORATION

Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use

• Primary Device ID: 10607915111660
• NIH Device Record Key: c94f427d-4fe7-420f-b9d3-d4695844182d
• Commercial Distribution Discontinuation: 2018-10-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acucise® Endopyelotomy System
• Version Model Number: B1005
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915111663 [Primary]
GS1	10607915111660 [Package]; Contains: 00607915111663; Package: [1 Units]; Discontinued: 2018-10-28; Not in Commercial Distribution

FDA Product Code

• KNY: Accessories, Catheter, G-U

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: 2019-04-15
• Device Publish Date: 2016-09-24

On-Brand Devices [Acucise® Endopyelotomy System]

• 10607915111677: General Purpose Ureteral Catheter
• 10607915111660: Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT