Catalog Number

-

Brand Name

ULTRA PROFILE

Version/Model Number

2450

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

-

Product Code

NBH

Product Code Name

Accessories, Arthroscopic

Public Device Record Key

17f5ae32-38f8-48c3-b69c-f7cead4090e3

Public Version Date

May 13, 2021

Public Version Number

2

DI Record Publish Date

January 11, 2021

Package DI Number

00857915007644

Quantity per Package

5

Contains DI Package

00857915007637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case