Curaplex - Curaplex Sterile, Gauze Pad, Woven, 4” x 4”, - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex Sterile, Gauze Pad, Woven, 4” x 4”, 12-ply, 1/Pk 100PK/BX

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More Product Details

Catalog Number

1212-12102

Brand Name

Curaplex

Version/Model Number

1212-12102

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Device Record Status

Public Device Record Key

d195b7d4-6b6c-4f94-9d91-1e3e465a3247

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

December 15, 2018

Additional Identifiers

Package DI Number

00812277030259

Quantity per Package

100

Contains DI Package

00812277030136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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