Catalog Number

-

Brand Name

Sklar

Version/Model Number

49-0965

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIY

Product Code Name

INSTRUMENT, FILLING, PLASTIC, DENTAL

Public Device Record Key

16e4f0e4-660b-4c4c-b3e9-9a4db36d5d86

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-