Catalog Number

PM1318-1

Brand Name

ProView plus

Version/Model Number

PM1318

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2016

Issuing Agency

In HIBCC

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

K953829,K953829

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

e3301599-6250-49b0-98e7-e59d7b88088c

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-