AccessGUDID - DEVICE: Reusable Acoustic Standoff Pad (00841436103725)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable Acoustic Standoff Pad
Version or Model: 610-460
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610-460
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436103725
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Reusable non-sterile (2 x 10 x 15cm)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992152	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Centimeter
Length: 15 Centimeter

Device Record Status

Public Device Record Key: ad0a5dab-8b7f-4a94-b36d-dbe2de4752dc
Public Version Date: September 03, 2021
Public Version Number: 4
DI Record Publish Date: August 22, 2017