Catalog Number

579862

Brand Name

Medical Device Accessories

Version/Model Number

579862

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2022

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Public Device Record Key

e86753aa-cac0-47ea-98e8-7f0a6b4085e9

Public Version Date

January 27, 2022

Public Version Number

2

DI Record Publish Date

December 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-