EMED Soluble Hemostatic Gauze - EMED Soluble Hemostatic Gauze - EMED TECHNOLOGIES CORPORATION

Duns Number:622637544

Device Description: EMED Soluble Hemostatic Gauze

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More Product Details

Catalog Number

EHEM22-10

Brand Name

EMED Soluble Hemostatic Gauze

Version/Model Number

EHEM22-10

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"

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

7286301e-0e61-4d5f-9de4-cc4985af58cf

Public Version Date

August 11, 2020

Public Version Number

3

DI Record Publish Date

January 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EMED TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26