Catalog Number

66800551

Brand Name

DURAFIBER 10X12 CM

Version/Model Number

66800551

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

ba2c6f14-31d4-4fb2-9a15-1eecc2674e43

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2020

Package DI Number

05000223467180

Quantity per Package

10

Contains DI Package

05000223467173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton