Catalog Number

-

Brand Name

Coretech

Version/Model Number

RHB2047

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

ed83c17f-7290-4639-aa8b-765edc417b8c

Public Version Date

November 19, 2021

Public Version Number

1

DI Record Publish Date

November 11, 2021

Package DI Number

10810041987294

Quantity per Package

10

Contains DI Package

00810041987297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case