Symmetry Rapidclean® ALLIS - Modular CFH Single Grasper, 5mmx33cm, RATCHET - SYMMETRY SURGICAL INC.

Duns Number:079641356

Device Description: Modular CFH Single Grasper, 5mmx33cm, RATCHET LOCK HANDLE

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More Product Details

Catalog Number

96-1088R

Brand Name

Symmetry Rapidclean® ALLIS

Version/Model Number

96-1088R

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

K974382

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

93a2f9ae-7bd0-401a-9fc3-37488d0d69d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 13, 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