Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

EP12-1707XL-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ILI

Product Code Name

Sling, Arm

Public Device Record Key

de971096-f9d9-49e7-ba1b-d6b20d2346ad

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

50840200305773

Quantity per Package

6

Contains DI Package

10840200305782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case