Catalog Number

EW-01-1

Brand Name

EasyWhip

Version/Model Number

EW-01-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210675,K210675

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

c4901bf0-eddc-45b0-9050-9cc735af4bd7

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Package DI Number

00860007711220

Quantity per Package

10

Contains DI Package

00860007711206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX