Catalog Number

20117

Brand Name

PCD Boot

Version/Model Number

5 Cell XL Zippered Boot

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161346

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

262461e9-6ef2-4fe8-a541-d7890d1af731

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-