Catalog Number

PBIIW

Brand Name

PRIMOBoot II w/wedge - Standard

Version/Model Number

PBIIW

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

1eca2b0a-3b1a-4078-8d0b-850f5685ef0d

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

10810006683605

Quantity per Package

8

Contains DI Package

00810006683608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case