Catalog Number

BL5627S

Brand Name

Synergetics

Version/Model Number

BL5627S

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

HQE

Product Code Name

Instrument, vitreous aspiration and cutting, ac-powered

Public Device Record Key

588aea93-bbc2-4c85-a6e9-2063f1a7108b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 30, 2017

Package DI Number

20841305111114

Quantity per Package

6

Contains DI Package

10841305111100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box