Catalog Number

HBP-S

Brand Name

TatumSurgical/Small Ball Housing

Version/Model Number

Small Ball Housing

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

EGG

Product Code Name

Attachment, Precision, All

Public Device Record Key

a9f8ebde-6107-4c8a-b6ca-a4e844d3c734

Public Version Date

July 15, 2022

Public Version Number

3

DI Record Publish Date

July 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-