Catalog Number

-

Brand Name

DB Surgical

Version/Model Number

S0090S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

2362b433-7f44-4e3e-b464-9282d56d2c23

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 09, 2018

Package DI Number

20843059121784

Quantity per Package

5

Contains DI Package

00843059121780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Subpack