E.M Adams co, inc. - BELT - E.M. ADAMS, INC.

Duns Number:001403807

Device Description: BELT

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More Product Details

Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP26-63350XL-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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

-

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

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

6ade4b93-a650-4f4b-b276-ff1960f92af9

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

December 31, 2019

Additional Identifiers

Package DI Number

58100013407371

Quantity per Package

48

Contains DI Package

18100013407380

Package Discontinue Date

February 28, 2021

Package Status

Not in Commercial Distribution

Package Type

Case

"E.M. ADAMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1447
2 A medical device with a moderate to high risk that requires special controls. 11