Catalog Number

-

Brand Name

PMI

Version/Model Number

PMITCSGXL

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"

Yes

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

HCF

Product Code Name

Instrument, Ligature Passing And Knot Tying

Public Device Record Key

e83779f5-54ed-427f-9d28-0730b7a6bfab

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

March 12, 2020

Package DI Number

00812608022069

Quantity per Package

10

Contains DI Package

00812608022052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box