AIRLOCK Centrolock - Centrolock drill bit Ø1.8 - NOVASTEP

Duns Number:264255288

Device Description: Centrolock drill bit Ø1.8

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More Product Details

Catalog Number

XDB01020

Brand Name

AIRLOCK Centrolock

Version/Model Number

XDB01020

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

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device Record Status

Public Device Record Key

002a35c1-48b4-4893-8a13-113c3b66ae57

Public Version Date

January 10, 2020

Public Version Number

1

DI Record Publish Date

January 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVASTEP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 494