AccuCARE Accessory Kit

Basic Information

• Brand Name: AccuCARE Accessory Kit
• Primary DI: 00841436103015
• Version / Model: 610-1293-5
• Catalog Number: 610-1293-5
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-22
• Public Version: 5
• Public Version Date: 2022-08-23
• Public Version Status: Update
• Public Device Record Key: d0de7a6a-a650-45bd-b3cf-3293766a30a1
• Distribution End Date: 2022-07-07

Device Description

Sterile 18GA grid (2), sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
JAQ	System, applicator, radionuclide, remote-controlled	Radiology	892.5700	2
IWJ	System, applicator, radionuclide, manual	Radiology	892.5650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38426	Prostate brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841436103015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131161	000
K970513	000
K992152	000

Device Sizes

Type	Value	Unit	Text
Width	3.2	Inch
Length	3.5	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight