Catalog Number

-

Brand Name

American Surgical Products

Version/Model Number

ASP16S

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

d6dc1386-a538-404f-b814-5dbb9849f9e6

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 08, 2018

Package DI Number

20843059121722

Quantity per Package

5

Contains DI Package

00843059121728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Subpack