Catalog Number

660-918500

Brand Name

Health-Tec Ultra Digital X-Ray Sensor Sheaths

Version/Model Number

660-918500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

f36347e2-a41e-4bc9-a8db-188d1613c833

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 17, 2017

Package DI Number

D7736609185003

Quantity per Package

20

Contains DI Package

D7736609185001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-