Symmetry QUAD-LOCK™ - Quadlock® Hand Grip, Ergonomic, Black - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: Quadlock® Hand Grip, Ergonomic, Black

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More Product Details

Catalog Number

50-9017

Brand Name

Symmetry QUAD-LOCK™

Version/Model Number

50-9017

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

K120117

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

fb8ab2d5-2d33-41ef-8a70-f6a3483d8f09

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

August 28, 2018

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