Catalog Number

-

Brand Name

NA

Version/Model Number

3655P38

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Public Device Record Key

fade8da2-d3ff-41ad-987d-755858a702b2

Public Version Date

April 02, 2021

Public Version Number

1

DI Record Publish Date

March 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-