FDA.reportPublic FDA data

Infiniti Plus™ Needle Guide

Primary DI
10841436102473
Brand
Infiniti Plus™ Needle Guide
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-1214, 610-1214-5
Catalog number
610-1214, 610-1214-5
Device description
Sterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer cover
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K093713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093713000ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMCivco Medical Instruments2010-01-19ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436102469PackageGS15Not in Commercial Distribution
00841436102476PackageGS124In Commercial Distribution
10841436102473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436102469008414361024698414361024690841436102469
00841436102476008414361024768414361024760841436102476
1084143610247310841436102473

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.6Inch
Width2.8Inch

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
Ethylene Oxide

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122061Verza Guidance System653-003653-0032026-07-23
00841436122672Needle Guide667-186667-1862026-07-23
00841436125338Biopsy Bracket667-195667-1952026-07-23
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
00841436125444Cradle657-108657-1082026-07-23
00841436125451Classic Stepper657-109657-1092026-07-23
00841436125819Biopsy Bracket642-522642-5222026-07-23
00841436125833Needle Guide Bracket642-524642-5242026-07-23
00841436125857Needle Guide Bracket642-526642-5262026-07-23
00841436126045Verza Guidance System657-110657-1102026-07-23
00841436126281Biopsy Bracket657-116657-1162026-07-23
00841436126304Biopsy Bracket657-118657-1182026-07-23
00841436126656Multi-Purpose Workstation ™ Stepper610-2561610-25612026-07-23
00841436126663Cradle610-2562610-25622026-07-23
00841436126670Storage System610-2559610-25592026-07-23
00841436126687Storage System610-2560610-25602026-07-23
10841436122662Needle Guide667-188667-188, 667-188-52025-12-31
00841436126311Tracking Bracket Starter Kit657-119657-1192025-12-31
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436122061Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
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00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
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00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29