Tec-Cide Plus - Tec-Cide Plus Glutaraldehyde 3%, Gallon - Dental Health Products Inc

Duns Number:623191194

Device Description: Tec-Cide Plus Glutaraldehyde 3%, Gallon

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More Product Details

Catalog Number

500-0001

Brand Name

Tec-Cide Plus

Version/Model Number

500-0001

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)

-

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

MED

Product Code Name

Sterilant, Medical Devices

Device Record Status

Public Device Record Key

13a4565d-6a4a-44e4-90a2-9f147f546890

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 26, 2017

Additional Identifiers

Package DI Number

20862632000315

Quantity per Package

4

Contains DI Package

10862632000318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DENTAL HEALTH PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 464
2 A medical device with a moderate to high risk that requires special controls. 78