FDA.reportPublic FDA data

Tracking Bracket

Primary DI
00841436120487
Brand
Tracking Bracket
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
657-087
Catalog number
657-087
Device description
Reusable non-sterile tracking bracket for use with Samsung Medison LM2-18 transducers
Published
2022-04-29
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
20841436120467Direct MarkingGS10
00841436120487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143612046720841436120467
00841436120487008414361204878414361204870841436120487

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
10841436101865eTRAX™ Needle610-1057610-10572017-08-29
10841436101889VirtuTRAX Instrument Navigator610-1059610-10592017-08-22
10841436102282VirtuTRAX Instrument Navigator610-1153610-11532017-08-22
10841436102435eTRAX™ Needle610-1213-10610-1213-102017-08-29
10841436102534eTRAX™ Needle610-1217-10610-1217-102017-08-29
10841436102640omniTRAX Patient Tracker610-1228610-12282017-08-22
10841436103128omniTRAX Active Patient Tracker610-1306610-13062017-08-22
10841436103289eTRAX™ Needle610-1413-10610-1413-102017-08-29
10841436103302eTRAX™ Needle610-1417-10610-1417-102017-08-29
10841436103395eTRAX™ Needle610-1613-10610-1613-102017-08-29
10841436103418eTRAX™ Needle610-1615-10610-1615-102017-08-29
10841436103531eTRAX™ Needle610-1815-10610-1815-102017-08-29
10841436103555eTRAX™ Needle610-1818-10610-1818-102017-08-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
00850050934288EndoSound® EVS™ SideKick 5107Endosound, Inc.IYO2026-10-30
00841517112776Sonosite MTFUJIFILM SONOSITE, INC.IYO2026-10-26
03770033463055FETOLYDIAGNOLYIYO2026-10-22
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
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00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
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08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
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00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
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