Vaginal Applicator Set

Basic Information

• Brand Name: Vaginal Applicator Set
• Primary DI: 00858012005465
• Version / Model: 710188
• Catalog Number: AG3000
• Company Name: Icad, Inc.
• Labeler DUNS: 108870254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5f30a3a6-a254-4982-ad6d-746e4e3a7fa4

Device Description

Vaginal Applicator Set

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAD	System, Therapeutic, X-Ray	Radiology	892.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59684	Intraoperative/postoperative therapeutic x-ray system vaginal applicator	A non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source when the system is used for intracavitary radiotherapy of the vagina. It is cylinder-shaped and may have an introduction-restricting guard. It is typically supplied in a range of sizes (diameters). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858012005465	GS1

Premarket Submissions

Submission Number	Supplement Number
K072616	000