Catalog Number

10-1102-1555

Brand Name

BandLoc DUO

Version/Model Number

10-1102-1555

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K161267,K200097

Product Code

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Public Device Record Key

94900513-3db2-42a8-8134-307ce9f1339a

Public Version Date

September 03, 2020

Public Version Number

2

DI Record Publish Date

February 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-