Catalog Number

Analog (SB) 5x14

Brand Name

Tatum Surgical-Analog

Version/Model Number

Analog (SB) 5x14

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 2020

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

K811923

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

c4b56b35-9fd6-47e3-ae5f-58c13f134ea6

Public Version Date

May 11, 2020

Public Version Number

2

DI Record Publish Date

February 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-