NORDENT MANUFACTURING INC - HANDLE MIRROR,COLOR RING,SIMPL - NORDENT MANUFACTURING INC

Duns Number:053187985

Device Description: HANDLE MIRROR,COLOR RING,SIMPL

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More Product Details

Catalog Number

-

Brand Name

NORDENT MANUFACTURING INC

Version/Model Number

HM22

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

-

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 Details

Product Code

EJB

Product Code Name

Handle, Instrument, Dental

Device Record Status

Public Device Record Key

15b54457-097d-455e-adea-f24bad11f36c

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORDENT MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5029
2 A medical device with a moderate to high risk that requires special controls. 5