Catalog Number

PMI-LK75-2974/45

Brand Name

AVALIGN

Version/Model Number

PMI-LK75-2974/45

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

HAE

Product Code Name

Rongeur, Manual

Public Device Record Key

68cfeb8f-2bfd-42a5-a7ed-4c1e6c75d936

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-