AccuSITE™ Needle Guide - Sterile needle guide (18ga) with (14x147cm) - CIVCO MEDICAL INSTRUMENTS CO., INC.

Duns Number:134614411

Device Description: Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision

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More Product Details

Catalog Number

610-2342

Brand Name

AccuSITE™ Needle Guide

Version/Model Number

610-2342

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093713,K093713

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

16546432-55aa-4b00-b754-1273268b870e

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

January 22, 2021

Additional Identifiers

Package DI Number

00841436120104

Quantity per Package

24

Contains DI Package

10841436120101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CIVCO MEDICAL INSTRUMENTS CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 443