Catalog Number

-

Brand Name

Axiom® Lig-A-Boots®

Version/Model Number

301

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

K820161,K820161,K820161,K820161

Product Code

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

ac272896-e45d-4d29-ba9b-95248d686e9c

Public Version Date

June 29, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2018

Package DI Number

M6653013

Quantity per Package

10

Contains DI Package

M6653011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case