Catalog Number

E5423

Brand Name

E5423 Band Bag with tape 81x91cm - 32"x36"

Version/Model Number

E5423

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101689,K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

c12a5314-9dc0-4434-9804-e51ecb32140d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2016

Package DI Number

00816953026697

Quantity per Package

40

Contains DI Package

00816953026680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case