Catalog Number

-

Brand Name

Axiom® Lig-A-Loops®

Version/Model Number

111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K800015,K800015,K800015,K800015

Product Code

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

b454cc39-69c7-4beb-8e6a-379ba5496925

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

September 23, 2018

Package DI Number

M6651115

Quantity per Package

60

Contains DI Package

M6651113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton