Catalog Number

058004

Brand Name

PRESTIGE INTRA-ORAL TIPS 48 PCS

Version/Model Number

058004

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

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

4ae5329e-a084-49df-8273-2392ac8b14db

Public Version Date

July 01, 2021

Public Version Number

2

DI Record Publish Date

September 06, 2019

Package DI Number

78033712562871

Quantity per Package

50

Contains DI Package

08033712562872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX