Distraction Screws Caspar type - Distraction Screws Caspar type - ACRA-CUT INC

Duns Number:612611459

Device Description: Distraction Screws Caspar type

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More Product Details

Catalog Number

800-501

Brand Name

Distraction Screws Caspar type

Version/Model Number

800-501

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

KDC

Product Code Name

Instrument, Surgical, Disposable

Device Record Status

Public Device Record Key

c602230a-c976-4e22-830c-4defd6bb5920

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 01, 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