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
00841436126311Tracking Bracket Starter Kit657-119657-1192025-12-31
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
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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