Catalog Number

PED-S1001

Brand Name

CureWrap™

Version/Model Number

Pediatric up to 4K (single)

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

-

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

f3ec8ace-6253-4a79-b6fd-0e55b7cd434b

Public Version Date

September 09, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

77290107580099

Quantity per Package

4

Contains DI Package

07290107580090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box