Forté® Plus Deflecting Access Sheath

GUDID 10607915113572

Ureteral Dilating Catheter

APPLIED MEDICAL RESOURCES CORPORATION

Ureteral stent-placement set

• Primary Device ID: 10607915113572
• NIH Device Record Key: cd84f1c1-f1ea-43cd-8465-113a1ed64d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forté® Plus Deflecting Access Sheath
• Version Model Number: B7331
• 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

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	00607915113575 [Primary]
GS1	10607915113572 [Package]; Contains: 00607915113575; Package: [1 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: 2016-08-15

On-Brand Devices [Forté® Plus Deflecting Access Sheath]

• 10607915113589: Ureteral Dilating Catheter
• 10607915113572: Ureteral Dilating Catheter