Catalog Number

-

Brand Name

Precept®

Version/Model Number

1011

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

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

0d9bbdf2-e7a9-430c-b8d9-feaf7318535c

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2018

Package DI Number

20814707020995

Quantity per Package

2

Contains DI Package

10814707020998

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case