Catalog Number

C2840

Brand Name

NA

Version/Model Number

C2840

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2021

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

K954682

Product Code

HTN

Product Code Name

WASHER, BOLT NUT

Public Device Record Key

4544398a-d4fa-4555-bafd-70cbbcba19d5

Public Version Date

September 01, 2021

Public Version Number

4

DI Record Publish Date

December 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-