OrthoMedFlex - Bipolar Head size 48 - ORTHOMEDFLEX LLC

Duns Number:034442726

Device Description: Bipolar Head size 48

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


More Product Details

Catalog Number

111-21-2848

Brand Name

OrthoMedFlex

Version/Model Number

111212848

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

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

K133370

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device Record Status

Public Device Record Key

51e19235-6697-483c-bc2a-409f7ea88b81

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

February 18, 2019

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