Symmetry Surgical - Symmetry® Knife Handle, Hardy Transsphenoidal - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: Symmetry® Knife Handle, Hardy Transsphenoidal Instrument, Vertical, 9 1/2 in, 241 mm

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More Product Details

Catalog Number

58-7578

Brand Name

Symmetry Surgical

Version/Model Number

58-7578

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

acd48c5f-a7e1-44f7-be6e-3c343789d731

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 08, 2017

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