E.M Adams co, inc. - ARM SLING - E.M. ADAMS, INC.

Duns Number:001403807

Device Description: ARM SLING

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP12-1707L-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

ILI

Product Code Name

Sling, Arm

Device Record Status

Public Device Record Key

5879e000-061b-4362-a83a-cc3a286ab5d1

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

December 31, 2019

Additional Identifiers

Package DI Number

58100013405711

Quantity per Package

6

Contains DI Package

18100013405720

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