FDA.reportPublic FDA data

Needle Guide

Primary DI
10841436122655
Brand
Needle Guide
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
667-187
Catalog number
667-187
Device description
Sterile endocavity needle guide for use with Philips eV14-2v transducers.
Published
2025-12-31
Public version status
New
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
K231783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231783000VitroPROCIVCO Medical Instruments Co., Inc.2023-11-14ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436122658PackageGS124In Commercial Distribution
10841436122655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436122658008414361226588414361226580841436122658
1084143612265510841436122655

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.

Storage And Handling#

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

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
No natural rubber latex
true
Sterilization required before use
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
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07070554100894Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
07070554100900Medistim QuickFit TTFM probeMedistim ASAITX2026-10-26
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