Catalog Number

-

Brand Name

Precept®

Version/Model Number

15101

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

6f1aa254-ff0e-4fb4-9d6d-131a43ef925d

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

September 18, 2018

Package DI Number

20814707020612

Quantity per Package

10

Contains DI Package

10814707020615

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case