Catalog Number

21.01HPXM

Brand Name

Synergetics

Version/Model Number

21.01HPXM

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

-

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

afd72f23-f890-4831-87e0-2b2656304e02

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

20841305110001

Quantity per Package

10

Contains DI Package

10841305109992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box