Catalog Number

1126704

Brand Name

Henry Schein

Version/Model Number

1126704

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

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

ebc63691-dfe3-4ea3-bd3b-eee4e2bd5f1c

Public Version Date

June 25, 2020

Public Version Number

1

DI Record Publish Date

June 17, 2020

Package DI Number

H65811267042

Quantity per Package

50

Contains DI Package

H65811267041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-