Catalog Number

70-811-0001

Brand Name

Citregen Tendon Sizing Kit

Version/Model Number

70-811-0001

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

K200725

Product Code

HWQ

Product Code Name

Passer

Public Device Record Key

8712189d-29ae-4c88-8240-7acc095d8728

Public Version Date

March 08, 2021

Public Version Number

2

DI Record Publish Date

November 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-