Catalog Number

-

Brand Name

BIKA BICANALICULAR INTUBATION SET J.A. BERNARD, M.D.

Version/Model Number

S1.1000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OKS

Product Code Name

Lacrimal Stents And Intubation Sets

Public Device Record Key

c64e83d2-7cac-4505-b93a-194a3221e9c0

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Package DI Number

33760087120104

Quantity per Package

3

Contains DI Package

03760087120103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-