Catalog Number

SDAG060QE080

Brand Name

SUTUMED

Version/Model Number

SDAG060QE080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K100780,K100780

Product Code

GAN

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC

Public Device Record Key

47c20d51-7eb5-4941-9c1d-589143cddc71

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

November 14, 2019

Package DI Number

07757093038375

Quantity per Package

12

Contains DI Package

07757093002956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX