Vaginal Applicator Set with Base and Clamp AG3010

GUDID 00858012005458

Vaginal Applicator Bundle 2

Icad, Inc.

Intraoperative/postoperative therapeutic x-ray system vaginal applicator

• Primary Device ID: 00858012005458
• NIH Device Record Key: 476d0c40-97e9-4b38-a7f0-134b64d4b1be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaginal Applicator Set with Base and Clamp
• Version Model Number: 720216
• Catalog Number: AG3010
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00858012005458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072616

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

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

[00858012005458]

Moist Heat or Steam Sterilization

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

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