FDA.reportPublic FDA data

Scanning Kit

Primary DI
10841436103623
Brand
Scanning Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-224
Catalog number
610-224
Device description
Non-sterile extension tube, (60cc) syringe and 3-way stopcock
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYDGenerator, low voltage, therapeutic x-ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYDGenerator, Low Voltage, Therapeutic X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895614000CIVCO LATEX ULTRASOUND SHEATHSCIVCO Medical Instruments Co., Inc.1989-12-14IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436103626PackageGS15Not in Commercial Distribution
10841436103623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436103626008414361036268414361036260841436103626
1084143610362310841436103623

GMDN Terms#

Term, Definition table
TermDefinition
Body-surface ultrasound imaging transducer coverA device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.37Inch
Total Volume60Milliliter

Storage And Handling#

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

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122078Biopsy Bracket653-004653-0042026-07-27
00841436122900Biopsy Bracket639-065639-0652026-07-27
00841436124294Biopsy Bracket642-520642-5202026-07-27
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436125895Needle Guide Starter Kit658-009658-0092026-07-27
00841436126052Biopsy Bracket657-111657-1112026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126366LED Instrument Cover610-2556610-25562026-07-27
00841436126403Needle Guide Starter Kit11713007117130072026-07-27
00841436126410Needle Guide Bracket11875211118752112026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436127028Verza Guidance System11821685118216852026-07-27
00841436127035Biopsy Bracket676-254676-2542026-07-27
10841436125311CIV-Clear™ Transducer Cover610-2512610-2512, 610-2512-52026-07-27
10841436125915Needle Guide867-010867-010, 867-010-52026-07-27
10841436125939Needle Guide857-004857-004, 857-004-52026-07-27
10841436125953Needle Guide842-009842-009, 842-009-52026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841436106174Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYD2017-08-22
00841436103626Scanning KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYD2017-08-22