Catalog Number

500012R

Brand Name

RE-CUR PVA/ALP®

Version/Model Number

RE-CUR PVA/ALP®1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140092,K140092

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

5a7c1e17-b8b3-4f16-b9de-f39a39407a25

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 26, 2019

Package DI Number

00857910006833

Quantity per Package

20

Contains DI Package

00857910006338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case 10 Pr