Symmetry Spurling - Kerrison Rongeur 40º Up 4mm 6" - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: Kerrison Rongeur 40º Up 4mm 6"

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More Product Details

Catalog Number

57-0514

Brand Name

Symmetry Spurling

Version/Model Number

57-0514

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K081651

Product Code Details

Product Code

HAE

Product Code Name

Rongeur, Manual

Device Record Status

Public Device Record Key

73deaaa5-2f9c-4c99-9400-a40ad73d4787

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 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