Catalog Number

35815

Brand Name

NobelProcera®

Version/Model Number

35815

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Public Device Record Key

1ac9807d-e7eb-48ef-8f77-6e852deb5960

Public Version Date

October 28, 2020

Public Version Number

2

DI Record Publish Date

September 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-