Catalog Number

051030

Brand Name

DISPENSER

Version/Model Number

051030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Public Device Record Key

11a329c8-cc6b-4a3a-9885-c671a19e618d

Public Version Date

October 04, 2021

Public Version Number

3

DI Record Publish Date

September 06, 2019

Package DI Number

88033712562854

Quantity per Package

10

Contains DI Package

08033712562858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX