Neo Sheets(100 pcs/box) - ATOM MEDICAL CORPORATION

Duns Number:690632047

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More Product Details

Catalog Number

60337

Brand Name

Neo Sheets(100 pcs/box)

Version/Model Number

60337

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"

-

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

-

Product Code Details

Product Code

KME

Product Code Name

Bedding, Disposable, Medical

Device Record Status

Public Device Record Key

320da13e-d56e-465b-aba5-835611e5026e

Public Version Date

January 29, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14942962603376

Quantity per Package

10

Contains DI Package

04942962603379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ATOM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 40