Catalog Number

BNS-1004

Brand Name

Stephens Instruments

Version/Model Number

BNS-1004

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140352,K140352

Product Code

LZU

Product Code Name

Plug, punctum

Public Device Record Key

ca187c4a-a75e-4b0b-94ba-2e57b5834ad0

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

00851807007163

Quantity per Package

20

Contains DI Package

00851807007125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box