Reusable Acoustic Standoff Pad 610-460

GUDID 00841436103725

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

CIVCO MEDICAL INSTRUMENTS CO., INC.

Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic Diagnostic ultrasound phantom, anthropomorphic
Primary Device ID00841436103725
NIH Device Record Keyad0a5dab-8b7f-4a94-b36d-dbe2de4752dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable Acoustic Standoff Pad
Version Model Number610-460
Catalog Number610-460
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Dimensions

Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter
Width10 Centimeter
Length15 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Storage Environment TemperatureBetween 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436103725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [Reusable Acoustic Standoff Pad]

00841436103725Reusable non-sterile (2 x 10 x 15cm)
00841436103718Reusable non-sterile (1 x 10 x 15cm)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.