AMD-RITMED VERSAGOWN - AMD-RITMED VERSAGOWN FLEXNECK IMPERVIOUS Level 2 - AMD Medicom Inc

Duns Number:256880576

Device Description: AMD-RITMED VERSAGOWN FLEXNECK IMPERVIOUS Level 2 Thumbloop Blue Medium

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More Product Details

Catalog Number

A69950

Brand Name

AMD-RITMED VERSAGOWN

Version/Model Number

A69950

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

OEA

Product Code Name

Non-surgical isolation gown

Device Record Status

Public Device Record Key

4eb5c89a-8baa-42be-955a-f5334f6bcf34

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 17, 2019

Additional Identifiers

Package DI Number

20686864055635

Quantity per Package

10

Contains DI Package

10686864055638

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