ClosureFast - Ultrasound Probe Cover,6"" x 96"" (15.2 cm x 2.4 - Covidien LP

Duns Number:058614483

Device Description: Ultrasound Probe Cover,6"" x 96"" (15.2 cm x 2.4 m)

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


More Product Details

Catalog Number

-

Brand Name

ClosureFast

Version/Model Number

PC-6X96

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 20, 2020

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"

Yes

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

K882724,K882724

Product Code Details

Product Code

KKX

Product Code Name

Drape, surgical

Device Record Status

Public Device Record Key

caa4dba7-8c8b-418a-b08e-d78d7d9a7abe

Public Version Date

May 05, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521058122

Quantity per Package

20

Contains DI Package

10884521058125

Package Discontinue Date

November 20, 2020

Package Status

Not in Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40