Catalog Number

131611

Brand Name

Kendall

Version/Model Number

131611

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

6b21c845-ba55-434c-9a6d-9fd40e8c24de

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

20884527014481

Quantity per Package

10

Contains DI Package

10884527014484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK