ELAN 4 - ELAN 4 MIS L13 DISP.DIAM.BURR X-CRS D5.0 - Aesculap AG

Duns Number:315018218

Device Description: ELAN 4 MIS L13 DISP.DIAM.BURR X-CRS D5.0

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More Product Details

Catalog Number

GP457SU

Brand Name

ELAN 4

Version/Model Number

GP457SU

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

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Device Record Status

Public Device Record Key

1737f775-a602-4ba3-bdc4-028306eef29e

Public Version Date

August 16, 2022

Public Version Number

4

DI Record Publish Date

January 31, 2019

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