Catalog Number

110025794

Brand Name

JUGGERKNOT

Version/Model Number

110025794

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

-

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

d6ca3298-8507-4488-a9bf-97242b526ae8

Public Version Date

August 09, 2019

Public Version Number

5

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-