FDA.reportPublic FDA data

Needle Guide

Primary DI
10841436122662
Brand
Needle Guide
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
667-188
Catalog number
667-188, 667-188-5
Device description
Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Philips eV14-2v transducers.
Published
2025-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00841436122665PackageGS124In Commercial Distribution
00841436126434PackageGS15In Commercial Distribution
10841436122662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436122665008414361226658414361226650841436122665
00841436126434008414361264348414361264340841436126434
1084143612266210841436122662

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
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
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24
04987670106088CONVEX ARRAY TRANSDUCERCANON INC.ITX2026-07-24
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
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16