Needle Guide - Sterile transvaginal needle guide with (2.6x20cm) - CIVCO MEDICAL INSTRUMENTS CO., INC.

Duns Number:134614411

Device Description: Sterile transvaginal needle guide with (2.6x20cm) and (3.5x20cm) latex coers for use with Sterile transvaginal needle guide with (2.6x20cm) and (3.5x20cm) latex coers for use with Hitachi, Ltd. C41V1 transducers

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More Product Details

Catalog Number

644-093, 644-093-5

Brand Name

Needle Guide

Version/Model Number

644-093, 644-093-5

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)

Yes

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

K970514,K970514,K970514

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

1a3107ba-9949-43e3-8996-80e94533ad82

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

January 21, 2021

Additional Identifiers

Package DI Number

00841436118507

Quantity per Package

24

Contains DI Package

10841436118504

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