AESCULAP - SC/MSC TRIAL INSERT 28MM 60/62 ASYM. - Aesculap AG

Duns Number:315018218

Device Description: SC/MSC TRIAL INSERT 28MM 60/62 ASYM.

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More Product Details

Catalog Number

NG495

Brand Name

AESCULAP

Version/Model Number

NG495

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2022

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

93f98326-f07c-4461-9f0f-37872cfdbf19

Public Version Date

May 03, 2022

Public Version Number

3

DI Record Publish Date

April 21, 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