AMD-RITMED - AMD-RITMED COHESIVE BANDAGE ROLL 2 Inch X 5 Yard - AMD Medicom Inc

Duns Number:256880576

Device Description: AMD-RITMED COHESIVE BANDAGE ROLL 2 Inch X 5 Yard

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More Product Details

Catalog Number

A2061-B

Brand Name

AMD-RITMED

Version/Model Number

A2061-B

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FQM

Product Code Name

BANDAGE, ELASTIC

Device Record Status

Public Device Record Key

11867d6b-0b1f-4267-a862-96fbe9276ae8

Public Version Date

April 23, 2019

Public Version Number

2

DI Record Publish Date

January 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2