Catalog Number

-

Brand Name

PeelVue Pro

Version/Model Number

37070

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

K162258,K162258,K162258

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

0e5699a7-6edf-4342-bb84-5315b4247f7e

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

20615375010277

Quantity per Package

10

Contains DI Package

10615375010270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE