Curaplex - Curaplex Personal Protection Kit with Large - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex Personal Protection Kit with Large Tychem Coverall

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More Product Details

Catalog Number

-

Brand Name

Curaplex

Version/Model Number

290900L

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)

Yes

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 Details

Product Code

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Device Record Status

Public Device Record Key

7dab580c-7a6d-41ba-9dc0-3224ff3d5a60

Public Version Date

April 07, 2021

Public Version Number

6

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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