Catalog Number

6000845N

Brand Name

Swaroplate

Version/Model Number

1285H

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"

Yes

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

K203494,K203494,K203494

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

a79be1f9-ab4c-47a0-8587-80fe2f553743

Public Version Date

May 06, 2021

Public Version Number

1

DI Record Publish Date

April 28, 2021

Package DI Number

35060441919602

Quantity per Package

8

Contains DI Package

15060441919608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box