Catalog Number

92-50828E

Brand Name

SmartLock

Version/Model Number

92-50828E

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

K190696,K190696

Product Code

JEY

Product Code Name

PLATE, BONE

Public Device Record Key

4d365350-834b-4d75-9dbb-eb56d9f899a8

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2019

Package DI Number

37613327459402

Quantity per Package

5

Contains DI Package

07613327459401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack