Catalog Number

57-2329

Brand Name

Symmetry Sypert

Version/Model Number

57-2329

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

K081651

Product Code

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

48aeb11f-7f2e-44fd-9378-48283c4a55a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-