Catalog Number

3910-400-100

Brand Name

TwinLoop FLEX

Version/Model Number

3910-400-100

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

HTW

Product Code Name

BIT, DRILL

Public Device Record Key

ca94fa75-63bd-4b4e-a52b-483c769dc357

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

34546540678226

Quantity per Package

5

Contains DI Package

04546540678225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack