Catalog Number

11-138-PP

Brand Name

EMPIRE SURGICAL INSTRUMENTS COMPANY

Version/Model Number

11-138-PP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code

LRW

Product Code Name

Scissors, General, Surgical

Public Device Record Key

1218bcb1-bd96-4773-8d48-270a7dea1307

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2022

Package DI Number

B92311138PP2

Quantity per Package

1000

Contains DI Package

B92311138PP11

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box