FDA.reportPublic FDA data

Reusable Acoustic Standoff Pad

Primary DI
00841436103718
Brand
Reusable Acoustic Standoff Pad
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-459
Catalog number
610-459
Device description
Reusable non-sterile (1 x 10 x 15cm)
Published
2017-08-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992152000GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFFCIVCO Medical Instruments Co., Inc.1999-08-17ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436103718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436103718008414361037188414361037180841436103718

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic ultrasound phantom, anthropomorphicA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

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00841436108331TEE Kit811-053811-0532017-08-22
00841436108348TEE Kit811-054811-0542017-08-22
00841436108355TEE Kit811-055811-0552017-08-22
00841436108362TEE Kit811-056811-0562017-08-22
00841436108379TEE Kit811-057811-0572017-08-22
00841436111133Laparostat810-212810-2122017-08-22
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