Aria Stem Size 0 Template - SIGNATURE ORTHOPAEDICS PTY LTD

Duns Number:751993028

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


More Product Details

Catalog Number

-

Brand Name

Aria Stem Size 0 Template

Version/Model Number

111-201-600

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

-

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

329067ca-3dd9-4679-9f94-ee4ac40a7086

Public Version Date

November 07, 2019

Public Version Number

1

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNATURE ORTHOPAEDICS PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1701
2 A medical device with a moderate to high risk that requires special controls. 3746