Catalog Number

-

Brand Name

ENVELOPE ARM SLING W/FM PAD XL

Version/Model Number

90000545

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)

-

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

ILI

Product Code Name

Sling, Arm

Public Device Record Key

78f62377-fbe4-427c-90af-56bb94d5a17b

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-