Curaplex - Curaplex Cold Pack, Medium - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex Cold Pack, Medium

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More Product Details

Catalog Number

1431-16002

Brand Name

Curaplex

Version/Model Number

1431-16002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

For Single-Use

Yes

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 Details

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Device Record Status

Public Device Record Key

f116a2e9-423d-4531-89fa-78f36201290c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 04, 2017

Additional Identifiers

Package DI Number

00817617025216

Quantity per Package

36

Contains DI Package

00817617025162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"BOUND TREE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 471
2 A medical device with a moderate to high risk that requires special controls. 540
3 A medical device with high risk that requires premarket approval 3
U Unclassified 1