Catalog Number

n/a

Brand Name

n/a

Version/Model Number

102-1089

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K180243

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

e49a480f-5077-4e2f-946a-800ec6d3bbff

Public Version Date

October 21, 2019

Public Version Number

2

DI Record Publish Date

August 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-