Catalog Number

-

Brand Name

PEAKOSIL

Version/Model Number

MSRC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152180,K152180,K152180

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

0cf486a4-20e9-4e57-a06a-15552c0c96fc

Public Version Date

June 30, 2021

Public Version Number

3

DI Record Publish Date

January 07, 2019

Package DI Number

18800026400025

Quantity per Package

4

Contains DI Package

08800026400028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-