Catalog Number

RSP163

Brand Name

N/A

Version/Model Number

N/A

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090308,K090308

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

6b8ed82c-a829-48c5-a83a-8d3947002979

Public Version Date

February 03, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

30885825017591

Quantity per Package

10

Contains DI Package

00885825017590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack