Plasmacup® - PLASMACUP MSC SIZE 66MM - Aesculap AG

Duns Number:315018218

Device Description: PLASMACUP MSC SIZE 66MM

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More Product Details

Catalog Number

NH166T

Brand Name

Plasmacup®

Version/Model Number

NH166T

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

78a71b09-d7f5-4eff-9a8b-71f45f95ffda

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

February 26, 2017

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