ACUMED - 9.0mm x 4.0mm Stem - Acumed LLC

Duns Number:196884852

Device Description: 9.0mm x 4.0mm Stem

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


More Product Details

Catalog Number

-

Brand Name

ACUMED

Version/Model Number

TR-S0904-S

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

KWI

Product Code Name

PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Device Record Status

Public Device Record Key

ef56cde8-1f28-4dd3-b31f-17192ad7f029

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUMED LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1870
2 A medical device with a moderate to high risk that requires special controls. 4532