Catalog Number

S-WB-CS1206

Brand Name

Phoenix Stainless Steel

Version/Model Number

S-WB-CS1206

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2020

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

DZD

Product Code Name

TUBE, ORTHODONTIC

Public Device Record Key

cef8ea58-9d6d-4274-8bd5-25b7aec36722

Public Version Date

September 24, 2020

Public Version Number

2

DI Record Publish Date

August 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-