Catalog Number

110025821

Brand Name

JUGGERKNOT

Version/Model Number

110025821

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K150768

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Public Device Record Key

93af487e-6abd-411c-bd5d-5cde98f8f525

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

April 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-