Catalog Number

-

Brand Name

Niceloop TT

Version/Model Number

3910-900-138

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

1bf96b76-21eb-432a-84c7-a2b7334afa5d

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Package DI Number

10810020089940

Quantity per Package

12

Contains DI Package

00810020089943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-