Catalog Number

C-079.05.000

Brand Name

SONTEC BLACK CASE

Version/Model Number

C-079.05.000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2021

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

-

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

ETF

Product Code Name

UNIT, EXAMINING/TREATMENT, ENT

Public Device Record Key

80c1236f-41e5-4a2d-ba0e-47293d809456

Public Version Date

January 05, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-