Catalog Number

-

Brand Name

E5470 Special Band Bag 50x22 opening 22cm (Top)

Version/Model Number

E5470

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

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

35856f07-6202-4940-9369-34174c595e94

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

10816953027035

Quantity per Package

80

Contains DI Package

00816953027038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case