Catalog Number

B0436658

Brand Name

DAFILON

Version/Model Number

B0436658

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)

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

e6009d3c-f3d9-40e1-8a64-8eaa7b7c4472

Public Version Date

October 15, 2021

Public Version Number

5

DI Record Publish Date

November 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-