Catalog Number

10-1201

Brand Name

RoG Single

Version/Model Number

10-1201

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113299,K113299

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

39291ded-a76b-4fee-9ce4-73c76f8a08f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

10855152006021

Quantity per Package

10

Contains DI Package

00855152006024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box