PLASMACUP SC - PLASMACUP SC X-RAY TEMPL.SZ.64-68MM SYM. - Aesculap AG

Duns Number:315018218

Device Description: PLASMACUP SC X-RAY TEMPL.SZ.64-68MM SYM.

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


More Product Details

Catalog Number

NG402

Brand Name

PLASMACUP SC

Version/Model Number

NG402

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

43268e3f-6ac3-4c4b-aebd-d01fcabe2f2b

Public Version Date

May 10, 2022

Public Version Number

2

DI Record Publish Date

May 20, 2020

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