iCAST

GUDID 00650862854435

iCAST COVERED STENT, 6MMX22MMX80CM

ATRIUM MEDICAL CORPORATION

Polymer-metal tracheal/bronchial stent, sterile

• Primary Device ID: 00650862854435
• NIH Device Record Key: a185eeb1-b200-495e-8abe-163d48804b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCAST
• Version Model Number: 85443
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL 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: false
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00650862854435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050814

FDA Product Code

• JCT: Prosthesis, tracheal, expandable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [iCAST]

• 00650862854558: iCAST COVERED STENT, 7MMX22MMX120CM
• 00650862854541: iCAST COVERED STENT, 7MMX16MMX120CM
• 00650862854534: iCAST COVERED STENT, 6MMX22MMX120CM
• 00650862854527: iCAST COVERED STENT, 6MMX16MMX120CM
• 00650862854510: iCAST COVERED STENT, 5MMX22MMX120CM
• 00650862854503: iCAST COVERED STENT, 5MMX16MMX120CM
• 00650862854459: iCAST COVERED STENT, 7MMX22MMX80CM
• 00650862854442: iCAST COVERED STENT, 7MMX16MMX80CM
• 00650862854435: iCAST COVERED STENT, 6MMX22MMX80CM
• 00650862854428: iCAST COVERED STENT 6MMX16MMX80CM
• 00650862854411: iCAST COVERED STENT, 5MMX22MMX80CM
• 00650862854404: iCAST COVERED STENT, 5MMX16MMX80CM
• 00650862854244: iCAST COVERED STENT, 10MMX38MMX120CM
• 00650862854206: iCAST COVERED STENT, 10MMX38MMX80CM
• 00650862854190: iCAST COVERED STENT, 9MMX59MMX120CM
• 00650862854183: iCAST COVERED STENT, 9MMX38MMX120CM
• 00650862854176: iCAST COVERED STENT, 8MMX59MMX120CM
• 00650862854169: iCAST COVERED STENT, 8MMX38MMX120CM
• 00650862854152: iCAST COVERED STENT, 7MMX59MMX120CM
• 00650862854145: iCAST COVERED STENT, 7MMX38MMX120CM
• 00650862854138: iCAST COVERED STENT, 6MMX59MMX120CM
• 00650862854121: iCAST COVERED STENT, 6MMX38MMX120CM
• 00650862854114: iCAST COVERED STENT, 5MMX59MMX120CM
• 00650862854107: iCAST COVERED STENT, 5MMX38MMX120CM
• 00650862854091: iCAST COVERED STENT, 9MMX59MMX80CM
• 00650862854084: iCAST COVERED STENT, 9MMX38MMX80CM
• 00650862854077: iCAST COVERED STENT, 8MMX59MMX80CM
• 00650862854060: iCAST COVERED STENT, 8MMX38MMX80CM
• 00650862854053: iCAST COVERED STENT, 7MMX59MMX80CM
• 00650862854046: iCAST COVERED STENT, 7MMX38MMX80CM
• 00650862854039: iCAST COVERED STENT, 6MMX59MMX80CM
• 00650862854022: iCAST COVERED STENT, 6MMX38MMX80CM
• 00650862854015: iCAST COVERED STENT, 5MMX59MMX80CM
• 00650862854008: iCAST COVERED STENT, 5MMX38MMX80CM