Catalog Number

-

Brand Name

SwannShidi

Version/Model Number

1110I-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121181

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

98717177-e896-4374-b7fa-26f5f8aea176

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-