OMNI Conical Stem - Anseris Conical Tapered Stem, Size 5 - Omni Life Science, Inc.

Duns Number:061339651

Device Description: Anseris Conical Tapered Stem, Size 5

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


More Product Details

Catalog Number

HC-32450

Brand Name

OMNI Conical Stem

Version/Model Number

HC-32450

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

LWJ

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Device Record Status

Public Device Record Key

6449f71e-9bd1-41f4-a72a-e8c127c15d80

Public Version Date

September 13, 2021

Public Version Number

3

DI Record Publish Date

September 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNI LIFE SCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1365