Catalog Number

-

Brand Name

Orthopli

Version/Model Number

OP3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

K101653

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

2269b959-514b-45f8-8c71-b065bc1d442b

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

August 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-