OrthoMedFlex - Tray, Tryon I Acetabular System - Upper and Lower - ORTHOMEDFLEX LLC

Duns Number:034442726

Device Description: Tray, Tryon I Acetabular System - Upper and Lower Tray

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

101-611

Brand Name

OrthoMedFlex

Version/Model Number

101-611

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

2651861f-0f51-491e-93c3-6d4e8692bc06

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOMEDFLEX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 371
2 A medical device with a moderate to high risk that requires special controls. 435