Balloon Applicator Kit AB2061

GUDID 00858012005328

Balloon Applicator, 4-5 cm Spherical

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system balloon applicator kit

• Primary Device ID: 00858012005328
• NIH Device Record Key: 9d76a2dd-0d46-499c-993a-a3f313047c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Applicator Kit
• Version Model Number: 720331
• Catalog Number: AB2061
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090914

FDA Product Code

• JAD: System, Therapeutic, X-Ray

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: 2016-09-20

On-Brand Devices [Balloon Applicator Kit]

• 00858012005342: Balloon Applicator, 5x7 cm Ellipsodial
• 00858012005335: Balloon Applicator, 5-6 cm Spherical
• 00858012005328: Balloon Applicator, 4-5 cm Spherical
• 00858012005311: Balloon Applicator, 3-4 cm Spherical