Symmetry RANEY - PERFORATED DRILL 1/2 - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: PERFORATED DRILL 1/2

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More Product Details

Catalog Number

26-1008

Brand Name

Symmetry RANEY

Version/Model Number

26-1008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 9999

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

HBG

Product Code Name

Drills, Burrs, Trephines & Accessories (Manual)

Device Record Status

Public Device Record Key

033a1e14-570c-4364-9241-98f1443569fa

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYMMETRY SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7981
2 A medical device with a moderate to high risk that requires special controls. 3309