Forté® AXP Access Sheath

GUDID 10607915113350

Ureteral Dilating Catheter

APPLIED MEDICAL RESOURCES CORPORATION

Ureteral stent-placement set Ureteral stent-placement set Ureteral stent-placement set

• Primary Device ID: 10607915113350
• NIH Device Record Key: dd9e3740-f64d-47a0-8769-f1c517f0f7a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forté® AXP Access Sheath
• Version Model Number: B7216
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 19497138300
• Email: contact@appliedmedical.com
• Phone: 19497138300
• Email: contact@appliedmedical.com
• Phone: 19497138300
• Email: contact@appliedmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 35 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915113353 [Primary]
GS1	10607915113350 [Package]; Contains: 00607915113353; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

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: 2016-08-11

On-Brand Devices [Forté® AXP Access Sheath]

• 10607915113558: Ureteral Dilating Catheter
• 10607915113534: Ureteral Dilating Catheter
• 10607915113510: Ureteral Dilating Catheter
• 10607915113497: Ureteral Dilating Catheter
• 10607915113350: Ureteral Dilating Catheter
• 10607915113336: Ureteral Stent Placement Set
• 10607915113299: Ureteral Stent Placement Set
• 10607915113275: Ureteral Stent Placement Set
• 10607915113220: Ureteral Stent Placement Set
• 10607915113206: Ureteral Stent Placement Set
• 10607915113183: Ureteral Stent Placement Set
• 10607915113169: Ureteral Stent Placement Set
• 10607915113145: Ureteral Stent Placement Set