Catalog Number

57-2947

Brand Name

Symmetry Surgical CASPAR ULTRA

Version/Model Number

57-2947

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 9999

Issuing Agency

In GS1

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

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

51e6b8d4-2364-4a0e-96f6-e137850c0198

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

June 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-