Catalog Number

AUDS-1600-PIG

Brand Name

Amplatz

Version/Model Number

G03102

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

GBO

Product Code Name

CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Public Device Record Key

d192734d-85ff-4fc1-a4ea-b3aa092e2a78

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-