Curaplex - Curaplex Cloth (Silk) White Adhesive Tape, 10 - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex Cloth (Silk) White Adhesive Tape, 10 yds, 1"

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More Product Details

Catalog Number

1841-14007

Brand Name

Curaplex

Version/Model Number

1841-14007

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

-

Prescription Use (Rx)

-

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

KGX

Product Code Name

Tape and bandage, adhesive

Device Record Status

Public Device Record Key

503ab042-1c57-4433-a5f6-8db450864a40

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

December 15, 2018

Additional Identifiers

Package DI Number

00812277031263

Quantity per Package

12

Contains DI Package

00812277031140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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