Catalog Number

ESD121-05-1, SD121-05-101, SD121-05-105

Brand Name

ATLAS Suture Delivery System

Version/Model Number

ESD121-05-1

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"

Yes

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

K193612,K193612,K193612

Product Code

KGC

Product Code Name

Tube, Gastro-Enterostomy

Public Device Record Key

654b1329-6f6f-4e75-86d5-df1952c4d29b

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

00842071131180

Quantity per Package

1

Contains DI Package

00842071131128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (SD121-05-101)