Balloon Applicator AB2070

GUDID 00858012005984

3-4 cm Spherical, Extended Length

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system balloon applicator kit

• Primary Device ID: 00858012005984
• NIH Device Record Key: fe8a7ad8-82ed-4eb3-9413-7e51b9b4f263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Applicator
• Version Model Number: 720846
• Catalog Number: AB2070
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005984 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-11-05

On-Brand Devices [Balloon Applicator]

• 00858012005991: 4-5 cm Spherical Extended Length
• 00858012005984: 3-4 cm Spherical, Extended Length
• 00850008977015: 5 x 7 cm Ellipsoidal, Extended Length
• 00850008977008: 5-6 cm Spherical Extended Length