ELAN 4 - ELAN 4 1-RING NEURO PRECISE D1.5 - AESCULAP, INC.

Duns Number:082594540

Device Description: ELAN 4 1-RING NEURO PRECISE D1.5

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


More Product Details

Catalog Number

US792SU

Brand Name

ELAN 4

Version/Model Number

US792SU

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

2f458ed6-7ee8-4e91-ab95-1e641c2a8c05

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3239
2 A medical device with a moderate to high risk that requires special controls. 683