Catalog Number

P00065

Brand Name

Quala Suture Silk

Version/Model Number

P00065

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GAL

Product Code Name

Suture, Absorbable, Natural

Public Device Record Key

bdafec51-bcee-4005-951b-375fcef86db3

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D023P000651

Quantity per Package

12

Contains DI Package

D023P0006509

Package Discontinue Date

-

Package Status

-

Package Type

-