Catalog Number

PPSGSHTX100

Brand Name

POSITION PERFECT

Version/Model Number

REV00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMR

Product Code Name

Device, Transfer, Patient, Manual

Public Device Record Key

e163e803-d1d9-489c-99a0-ac0d7346d227

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

30603354120014

Quantity per Package

2

Contains DI Package

10603354120027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box