Catalog Number

-

Brand Name

PEAKOSIL

Version/Model Number

NS017C

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

ed2ad775-b273-4bf5-85f3-ecb62758fc07

Public Version Date

June 30, 2021

Public Version Number

8

DI Record Publish Date

September 20, 2017

Package DI Number

18800026400001

Quantity per Package

4

Contains DI Package

08800026400004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX