COVIDIEN - 10ML PREFILLED SYRINGE - NURSE ASSIST, INC.

Duns Number:869434464

Device Description: 10ML PREFILLED SYRINGE

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

COVIDIEN

Version/Model Number

6496722

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030813,K030813

Product Code Details

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Device Record Status

Public Device Record Key

b77d39cc-f1f9-4b22-857c-a9f173c535b2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NURSE ASSIST, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 48
U Unclassified 7