Dura Separator, Baker, Reusable - Dura Separator, Baker, Reusable 2.5mm #0 - ACRA-CUT INC

Duns Number:612611459

Device Description: Dura Separator, Baker, Reusable 2.5mm #0

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More Product Details

Catalog Number

800-715

Brand Name

Dura Separator, Baker, Reusable

Version/Model Number

800-715

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)

-

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

caffb6d8-1c3e-410b-b374-b66d0f36e440

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2017

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