Catalog Number

-

Brand Name

SILC

Version/Model Number

1116.0006S

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133482

Product Code

OWI

Product Code Name

Bone fixation cerclage, sublaminar

Public Device Record Key

afb3e5a0-f5dd-4ed8-9122-3c49fca5e5d0

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

November 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-