FDA.reportPublic FDA data

Needle Guide Starter Kit

Primary DI
00841436107013
Brand
Needle Guide Starter Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
674-037
Catalog number
674-037
Device description
Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) with (10.2 x 147cm) CIV-Flex™ cover for use with SonoSite L25 transducers (18GA)
Published
2017-08-22
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
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030064000ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYSonosite,Inc.2003-01-22ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436115333Direct MarkingGS10
00841436107013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143611533320841436115333
00841436107013008414361070138414361070130841436107013

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a 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 many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.8Inch
Width1.2Inch

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10841436122662Needle Guide667-188667-1882025-12-31
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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