Forté® HD Access Sheath

GUDID 10607915113381

Ureteral Dilating Catheter

APPLIED MEDICAL RESOURCES CORPORATION

Ureteral stent-placement set

• Primary Device ID: 10607915113381
• NIH Device Record Key: d01c0a2a-7515-4c58-ad31-776d1ff25f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forté® HD Access Sheath
• Version Model Number: B7217
• 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: 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915113384 [Primary]
GS1	10607915113381 [Package]; Contains: 00607915113384; 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: 2016-08-12

On-Brand Devices [Forté® HD Access Sheath ]

• 10607915113565: Ureteral Dilating Catheter
• 10607915113541: Ureteral Dilating Catheter
• 10607915113527: Ureteral Dilating Catheter
• 10607915113503: Ureteral Dilating Catheter
• 10607915113381: Ureteral Dilating Catheter
• 10607915113343: Ureteral Dilating Catheter
• 10607915113329: Ureteral Stent Placement Set
• 10607915113282: Ureteral Stent Placement Set
• 10607915113268: Ureteral Stent Placement Set
• 10607915113213: Ureteral Stent Placement Set
• 10607915113190: Ureteral Stent Placement Set
• 10607915113176: Ureteral Stent Placement Set
• 10607915113152: Ureteral Stent Placement Set