Excia® L - EXCIA L CEMENTED 12/14 SIZE 17MM - Aesculap AG

Duns Number:315018218

Device Description: EXCIA L CEMENTED 12/14 SIZE 17MM

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


More Product Details

Catalog Number

NK997K

Brand Name

Excia® L

Version/Model Number

NK997K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2018

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

JDI

Product Code Name

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

Device Record Status

Public Device Record Key

e54de107-bba7-4d13-9eec-31fb8951c2c2

Public Version Date

October 27, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11840
2 A medical device with a moderate to high risk that requires special controls. 7088
3 A medical device with high risk that requires premarket approval 37