Catalog Number

216193

Brand Name

GII ETHIBOND

Version/Model Number

216193

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

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

GAS

Product Code Name

Suture, nonabsorbable, synthetic, polyester

Public Device Record Key

f8cde009-ab31-4783-b3ac-ce2390298a01

Public Version Date

January 28, 2021

Public Version Number

6

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-