Catalog Number

GCS40B

Brand Name

ECHELON

Version/Model Number

GCS40B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

GDW

Product Code Name

Staple, implantable

Public Device Record Key

549daf4b-0f6a-4df6-bc33-7881eb37313d

Public Version Date

December 14, 2021

Public Version Number

1

DI Record Publish Date

December 06, 2021

Package DI Number

20705036027512

Quantity per Package

3

Contains DI Package

10705036027515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX