Catalog Number

72204158

Brand Name

DYONICS

Version/Model Number

72204158

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

b2e14526-65c3-4e7f-aa79-9d2686e3d4db

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

April 12, 2016

Package DI Number

20885554033674

Quantity per Package

6

Contains DI Package

00885554033670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX