Catalog Number

055107

Brand Name

PRESTIGE HYDROLIGHT 2X50 ML+12 YELLOW MIXING TIPS

Version/Model Number

055107

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 30, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K083739,K083739

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

0f14dad1-922e-4ba1-8a23-98b9379ba507

Public Version Date

July 31, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2019

Package DI Number

00803371256256

Quantity per Package

29

Contains DI Package

00803371256171

Package Discontinue Date

July 30, 2020

Package Status

Not in Commercial Distribution

Package Type

KIT