Catalog Number

B0935739

Brand Name

DAFILON

Version/Model Number

B0935739

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

Suture, nonabsorbable, synthetic, polyamide

Public Device Record Key

f435dd0f-cfa1-4250-9aa0-7b5bd524314d

Public Version Date

March 17, 2022

Public Version Number

1

DI Record Publish Date

March 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-