Catalog Number

-

Brand Name

PROBASICS

Version/Model Number

BS16GB

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IKX

Product Code Name

Aid, Transfer

Public Device Record Key

449c89ed-1678-408d-af53-08bfa9d26a84

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

30815067072027

Quantity per Package

25

Contains DI Package

00815067072026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX