MEDICOM - MEDICOM COTTON DENTAL ROLL 1 1/2 X 3/8 Inch - AMD Medicom Inc

Duns Number:256880576

Device Description: MEDICOM COTTON DENTAL ROLL 1 1/2 X 3/8 Inch

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More Product Details

Catalog Number

4554

Brand Name

MEDICOM

Version/Model Number

4554

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)

-

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

EFN

Product Code Name

COTTON, ROLL

Device Record Status

Public Device Record Key

48157d07-e9f5-4b8e-97e1-d3864a2b790c

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Additional Identifiers

Package DI Number

20686864048552

Quantity per Package

12

Contains DI Package

10686864048555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case

"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