C-Mor Dental Mirror - No. 5 sized Stainless Steel, Cone Socket, Front - ESSENTIAL DENTAL SYSTEMS, INC.

Duns Number:101147171

Device Description: No. 5 sized Stainless Steel, Cone Socket, Front Surface Mirror Heads

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

5004-05

Brand Name

C-Mor Dental Mirror

Version/Model Number

5004-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

EAX

Product Code Name

MIRROR, MOUTH

Device Record Status

Public Device Record Key

94d409c3-bfab-4a85-9edf-7044b1c9e3b8

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESSENTIAL DENTAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 249
2 A medical device with a moderate to high risk that requires special controls. 26
U Unclassified 3