Catalog Number

72204177

Brand Name

DYONICS

Version/Model Number

72204177

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GFF

Product Code Name

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

8e1dd0f4-b4ae-47fe-9511-6957f02ab8c9

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

April 12, 2016

Package DI Number

20885554033698

Quantity per Package

6

Contains DI Package

00885554033694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX