Catalog Number

BI-001

Brand Name

Bi-Manual, 21 Gauge, Straight Open End, Irrigation

Version/Model Number

BI-001

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYG

Product Code Name

Device, Irrigation, Ocular Surgery

Public Device Record Key

9d107330-fd31-49ea-bddb-6cb6e183c3d2

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

September 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-