Catalog Number

BL5240

Brand Name

Synergetics

Version/Model Number

BL5240

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

HMX

Product Code Name

Cannula, ophthalmic

Public Device Record Key

dc678287-67cd-453e-8c0f-aca459ac2f6c

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

June 26, 2017

Package DI Number

20841305111374

Quantity per Package

6

Contains DI Package

10841305111360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box