Catalog Number

SC-8CM

Brand Name

STIFFENING CANNULA, 8CM F/G

Version/Model Number

8CM

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"

Yes

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

K845038,K845038,K845038

Product Code

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

370fd504-60e1-42d0-b6c4-6bdfaf618d36

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

May 04, 2017

Package DI Number

20858690006628

Quantity per Package

50

Contains DI Package

10858690006621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case