Reusable Acoustic Standoff Pad

Basic Information

• Brand Name: Reusable Acoustic Standoff Pad
• Primary DI: 00841436103725
• Version / Model: 610-460
• Catalog Number: 610-460
• 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: 4
• Public Version Date: 2021-09-03
• Public Version Status: Update
• Public Device Record Key: ad0a5dab-8b7f-4a94-b36d-dbe2de4752dc
• Distribution End Date: 2020-12-17

Device Description

Reusable non-sterile (2 x 10 x 15cm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
40625	Diagnostic ultrasound phantom, anthropomorphic	A device that consists of preserved human or animal tissue, or a tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ, organ systems or blood flow. It is a quality assurance (QA) device intended to permit both subjective and quantitative evaluation of the performance of ultrasound image acquisition and display systems and associated image acquisition, display, and analysis computer programs. Designs can incorporate fluid pumps and software or microprocessor controls. This GMDN code includes Doppler flow, ultrasound mammography, biopsy, and interventional training phantoms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841436103725	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992152	000

Device Sizes

Type	Value	Unit	Text
Width	10	Centimeter
Length	15	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit