ACRA-CUT - Disposable Cranial Perforator - ACRA-CUT INC

Duns Number:612611459

Device Description: Disposable Cranial Perforator

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More Product Details

Catalog Number

200-271

Brand Name

ACRA-CUT

Version/Model Number

14/11mm DGR-O

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)

-

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

HBF

Product Code Name

Drills, Burrs, Trephines & Accessories (Compound, Powered)

Device Record Status

Public Device Record Key

09c3d37b-b160-4749-8651-48ee4f3192c3

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACRA-CUT INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 42