Biogel Eclipse® - Biogel Eclipse 7.0 x50 US - Mölnlycke Health Care AB

Duns Number:631770658

Device Description: Biogel Eclipse 7.0 x50 US

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


More Product Details

Catalog Number

-

Brand Name

Biogel Eclipse®

Version/Model Number

75270

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K053443,K053443,K053443

Product Code Details

Product Code

KGO

Product Code Name

Surgeon's gloves

Device Record Status

Public Device Record Key

61d972e3-0696-4ef9-a43a-a2e7fd3b06cd

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

05060097930678

Quantity per Package

4

Contains DI Package

05060097930593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MÖLNLYCKE HEALTH CARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 212
2 A medical device with a moderate to high risk that requires special controls. 15
U Unclassified 18