Catalog Number

-

Brand Name

Surgical Support Tie

Version/Model Number

SL-xxxxx

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"

-

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

GAE

Product Code Name

SNARE, SURGICAL

Public Device Record Key

f22fab5f-14cf-4747-9f77-b2dc17457568

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2015

Package DI Number

10803622128414

Quantity per Package

60

Contains DI Package

00803622128417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE