Catalog Number

-

Brand Name

Precept®

Version/Model Number

6601

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

7b7429e9-cea6-4880-b872-4d7d9d4e1bd2

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 2018

Package DI Number

20814707020704

Quantity per Package

25

Contains DI Package

00814707020700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case