Catalog Number

1127296

Brand Name

Henry Schein

Version/Model Number

1127296

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GDX

Product Code Name

SCALPEL, ONE-PIECE

Public Device Record Key

d4f24656-96a5-4f91-9d2e-41dbe299b83f

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

20304040052369

Quantity per Package

100

Contains DI Package

10304040052362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case