Catalog Number

40-101-1080

Brand Name

CitreLock 8.0mm Reamer

Version/Model Number

40-101-1080

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

-

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

K200725

Product Code

HTO

Product Code Name

Reamer

Public Device Record Key

e9b712ea-a6c4-4840-9f27-efbf1170f84d

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-