Catalog Number

-

Brand Name

Precept®

Version/Model Number

15216

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

K771409,K771409,K771409

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

abe67245-cdb1-4ee7-8e24-9561504a1679

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

August 05, 2016

Package DI Number

20814707020148

Quantity per Package

6

Contains DI Package

10814707020141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE