Catalog Number

-

Brand Name

FlexBand Plus

Version/Model Number

41051

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

K192112

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

5263e094-53ac-42c0-ad15-10d53d0c56b0

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-