Catalog Number

RSP160

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

d9bb1c78-4af0-44d7-806a-c076d4cf5bf2

Public Version Date

February 03, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

30885825017584

Quantity per Package

10

Contains DI Package

00885825017583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack