FDA.reportPublic FDA data

Starter Kit

Primary DI
00841436109338
Brand
Starter Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
H4908NF
Catalog number
H4908NF
Device description
Reusable non-sterile Volume Navigation Sensor bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5) for use with GE Healthcare IC5-9-D transducers
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092619000ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERCivco2009-11-13IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436115418Direct MarkingGS10
00841436109338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143611541820841436115418
00841436109338008414361093388414361093380841436109338

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system tracking holder, reusableA device intended to be used with a hand-held ultrasound (US) imaging system transducer to provide a means to attach/hold an electromagnetic (EM) sensor or needle guide to the distal end of the US transducer in a repeatable position (can detach/reattach to same place on transducer). It is a metal/plastic bracket available in various dimensions that is manually applied to the US transducer. It is typically used in conjunction with an electromagnetic device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.35Inch
Length2.33Inch

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22
00841436108317TEE Kit811-051811-0512017-08-22
00841436108324TEE Kit811-052811-0522017-08-22
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
10841436122655Needle Guide667-187667-1872025-12-31
10841436122662Needle Guide667-188667-1882025-12-31
10841436126240Needle Guide610-1557610-15572025-12-31
10841436126257Needle Guide610-1558610-15582025-12-31
00841436122894Verza Guidance System639-064639-0642025-12-31
00841436125345Verza Guidance System667-196667-1962025-12-31
00841436125802Verza Guidance SystemH48062APH48062AP2025-12-31
00841436125826Needle Guidance SystemH48062ARH48062AR2025-12-31
00841436125840Needle Guidance SystemH48062ASH48062AS2025-12-31
00841436126274Verza Guidance System657-115657-1152025-12-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
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00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
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00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
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08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20