Catalog Number

X1046711

Brand Name

Safil Quick

Version/Model Number

X1046711

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 24, 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

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

b892e3ed-27fc-4636-8728-db841940aa08

Public Version Date

February 28, 2022

Public Version Number

8

DI Record Publish Date

July 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-