AESCULAP - ELAN 4 FIXED DURAGUARD PAEDIATRIC - Aesculap AG

Duns Number:315018218

Device Description: ELAN 4 FIXED DURAGUARD PAEDIATRIC

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More Product Details

Catalog Number

GB941R

Brand Name

AESCULAP

Version/Model Number

GB941R

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

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Device Record Status

Public Device Record Key

60c77e07-34b3-4d86-899f-2bdf167f7465

Public Version Date

April 27, 2021

Public Version Number

3

DI Record Publish Date

November 25, 2016

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