Catalog Number

-

Brand Name

CTC DVT Sleeve

Version/Model Number

RM-VP-501L

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

Yes

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

K093658,K093658

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

4fdd0570-c0f0-4509-99aa-c44a3af4c26f

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

10816317020368

Quantity per Package

10

Contains DI Package

00816317020361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE